Data / Medical devices / United States / Howmedica Osteonics Corp
Howmedica Osteonics Corp: FDA-registered device maker in Mahwah, NJ, United States, 240 510(k) clearances and 2 PMA approvals
Howmedica Osteonics Corp is registered with the FDA (registration 2249697) in Mahwah, NJ, United States. It lists 63 device types. The FDA files 240 510(k) clearances and 2 PMA approvals under its listings, the newest dated August 6, 2026. 226 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2249697
- FEI number
- 3003070421
- Address
- 325 Corporate DR., Mahwah, NJ, United States, 07430
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer, Specification developer
- First device listed
- November 23, 1992
- Registered through
- 2027
- Brand names listed
- ., 1.3MM X 35.6CM NITINOL GUIDE WIRE, 1.9MM OBTURATOR, 1.9MM SPEEDLOCK PENCIL TIP OBTURATOR, 1.9MM TROCAR, 100MM DRAIN CANNULA, 10MM DRAIN CANNULA, 10mm SUBFIX TRIAL and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 240.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 6, 2026 | K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | KRO | Substantially Equivalent | Howmedica Osteonics Corp. dba Stryker Orthopaedics | accessdata.fda.gov |
| July 10, 2026 | K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component | LPH | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| February 18, 2026 | K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | MBH | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| December 15, 2025 | K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper | KRO | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| October 24, 2025 | K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | MBH | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| July 25, 2025 | K251665 | Triathlon® Hinge Knee System | KRO | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| July 25, 2025 | K250989 | Stryker and Serf hip devices | LPH | Substantially Equivalent | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | accessdata.fda.gov |
| February 6, 2025 | K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert Posteriorly Stabilized Insert | JWH | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| February 6, 2025 | K243784 | Stryker Orthopaedics Hip Devices Labeling Update | LPH | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| December 4, 2024 | K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System | JWH | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| August 2, 2024 | K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | JDI | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| April 24, 2024 | K234025 | 22.2mm BIOLOX® delta Ceramic V40 Femoral Heads | LZO | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| April 12, 2024 | K240418 | Stryker Orthopaedics Hip Systems Labeling Update | JDI | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| March 11, 2024 | K233724 | 28mm/38D MDM X3 Insert for MDM Liner | LZO | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| December 21, 2023 | K233498 | Stryker Orthopaedics Hip Systems Labeling Update | LPH | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| December 8, 2023 | K233261 | Global Modular Replacement System | JDI | Substantially Equivalent | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | accessdata.fda.gov |
| June 2, 2023 | K230952 | Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component | JWH | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| May 19, 2023 | K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | KRO | Substantially Equivalent | Stryker | accessdata.fda.gov |
| April 21, 2023 | K223069 | Modular Rotating Hinge Knee Systems and Compatible Components | KRO | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| January 26, 2023 | K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee | JDI | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| January 20, 2023 | K223528 | Triathlon® Hinge Knee System | KRO | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| October 21, 2022 | K222632 | UHR Bipolar Implants, Restoration GAP II Implants | KWL | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| August 11, 2022 | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | MEH | Substantially Equivalent | Stryker | accessdata.fda.gov |
| June 2, 2022 | K220930 | Restoris Multi-Compartmental Knee System | HSX | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| May 20, 2022 | K220838 | Artisan Bone Plug, Universal Cement Restrictor | LZN | Substantially Equivalent | Howmedica Osteonics, Dba Stryker Orthopaedics | accessdata.fda.gov |
| March 9, 2022 | K220376 | Acetabular Dome Hole Plug | LPH | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| March 1, 2022 | K212187 | Restoration® Modular Hip System | LPH | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| February 1, 2022 | K213701 | Exeter® X3® RimFit® Cup | JDI | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| December 21, 2021 | K213129 | Restoration Modular 115mm Conical Distal Stem | LZO | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| August 16, 2021 | K211703 | Insignia Hip Stem | MEH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| June 4, 2021 | K211303 | Avon Patello-femoral Joint Prosthesis | KRR | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| April 22, 2021 | K210893 | Restoration Anatomic Shell | LPH | Substantially Equivalent | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | accessdata.fda.gov |
| October 27, 2020 | K203099 | Triathlon PKR System | HSX | Substantially Equivalent | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | accessdata.fda.gov |
| October 16, 2020 | K202016 | Dall-Miles® Cable System | JDQ | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| August 13, 2020 | K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | JDI | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| May 27, 2020 | K193233 | Restoration® Modular Hip System | LPH | Substantially Equivalent | Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) | accessdata.fda.gov |
| May 13, 2020 | K200782 | Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite | MBH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| October 24, 2019 | K191358 | Trident II Acetabular System | LPH | Substantially Equivalent | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | accessdata.fda.gov |
| August 28, 2019 | K191414 | EXETER Centralizer, EXETER 2.5mm Plug | JDI | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| August 22, 2019 | K190402 | Triathlon Total Knee System-Additional Components | JWH | Substantially Equivalent | Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) | accessdata.fda.gov |
| August 15, 2019 | K190991 | Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment | MBH | Substantially Equivalent | Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) | accessdata.fda.gov |
| March 19, 2019 | K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System | LPH | Substantially Equivalent | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | accessdata.fda.gov |
| June 7, 2018 | K180612 | Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts | HSX | Substantially Equivalent | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | accessdata.fda.gov |
| March 19, 2018 | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | JDG | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| February 2, 2018 | K173849 | Triathlon Total Knee System | MBH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| November 16, 2017 | K172634 | Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components | MBH | Substantially Equivalent | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | accessdata.fda.gov |
| October 30, 2017 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | JWH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| October 2, 2017 | K171768 | Trident® II Acetabular System | LPH | Substantially Equivalent | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | accessdata.fda.gov |
| October 14, 2016 | K161569 | Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws | LPH | Substantially Equivalent | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | accessdata.fda.gov |
| May 25, 2016 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | LPH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| August 10, 2015 | K151264 | Restoration Anatomic Shell | LPH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| March 20, 2015 | K150410 | RESTORIS POROUS PARTIAL KNEE SYSTEM | HRY | Substantially Equivalent | Mako Surgical Corporation | accessdata.fda.gov |
| March 10, 2015 | K150307 | RESTORIS Multicompartmental Knee System | NPJ | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| February 9, 2015 | K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach | LPH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| January 13, 2015 | K143393 | Triathlon Tritanium Cone Augments | MBH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| November 14, 2014 | K142462 | Restoration Anatomic Shell | LPH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| August 5, 2014 | K141056 | TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS | MBH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| November 26, 2013 | K132624 | TRIATHLON TRITANIUM METAL-BACKED PATELLA | MBH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| August 16, 2013 | K123604 | ABG III MONOLITHIC HIP STEM | MAY | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| May 3, 2013 | K123486 | TRIATHLON TRITANIUM TIBIAL BASEPLATE | MBH | Substantially Equivalent | Stryker | accessdata.fda.gov |
| February 22, 2013 | K122015 | DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE | KRO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| February 14, 2013 | K123166 | TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| February 1, 2013 | K122853 | NOVEL FIT AND FILL STEM | MEH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| July 30, 2012 | K121308 | HIP SYSTEMS | LPH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| September 28, 2011 | K112556 | ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS | MEH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 3, 2011 | K102019 | RESTORATION ACETABULAR WEDGE AUGMENTS | LPH | Substantially Equivalent | Howmedica Osteonics | accessdata.fda.gov |
| February 3, 2011 | K103233 | MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT | LZO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| October 26, 2010 | K103010 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT | KKY | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| December 18, 2009 | K093644 | RESTORATION ADM SYSTEM X3 ACETABULAR | MEH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| October 23, 2009 | K090897 | TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT | LPH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| October 3, 2008 | K082567 | STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION | HRY | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| July 22, 2008 | K081171 | TRITANIUM ACETABULAR SHELL SYSTEM | LPH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| January 7, 2008 | K072575 | TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE | MBH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| October 15, 2007 | K072221 | MODIFICATION TO TRIATHLON TS KNEE SYSTEM | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| October 9, 2007 | K071881 | TRIATHLON PKR SYSTEM | HRY | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| August 15, 2007 | K071991 | MODIFICATION TO SCORPIO NRG KNEE SYSTEM | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| June 1, 2007 | K070095 | TRIATHLON TS KNEE SYSTEM | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| May 16, 2007 | K070885 | UNIVERSAL TAPER DELTA FEMORAL HEAD | LZO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| May 11, 2007 | K070883 | DURACON X3 CS TIBIAL INSERT | MBH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| May 4, 2007 | K070963 | REUNION HA FRACTURE STEM | HSD | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 8, 2007 | K063552 | SERIES II CONSTRAINED ACETABULAR LINERS | KWZ | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 8, 2007 | K063550 | SYSTEM 12 CONSTRAINED ACETABULAR LINERS | KWZ | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 8, 2007 | K063445 | PCA CONSTRAINED ACETABULAR LINERS | KWZ | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| February 26, 2007 | K063857 | SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT | MBB | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| January 22, 2007 | K063423 | TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT | JWH | Substantially Equivalent | Howmedica Osteonics | accessdata.fda.gov |
| January 8, 2007 | K062553 | SIMPLEX P BONE CEMENT | LOD | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| December 13, 2006 | K062845 | MODULAR REPLACEMENT ELBOW SYSTEM | HSD | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| November 15, 2006 | K062419 | TRIDENT LARGE DIAMETER ACETABULAR INSERTS | LPH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| August 22, 2006 | K061434 | TRIDENT LARGE DIAMETER HIP SYSTEM | LPH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| August 11, 2006 | K061521 | TRIATHLON METAL BACKED PATELLA | MBH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| August 3, 2006 | K062037 | TRIATHLON LOW PROFILE TIBIAL TRAY | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| July 18, 2006 | K061168 | PCA 36MM FEMORAL HEADS | LPH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| July 7, 2006 | K061654 | TRIDENT CONSTRAINED ACETABULAR INSERT | KWZ | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| January 26, 2006 | K053514 | TRIATHLON TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| January 26, 2006 | K053198 | SIMPLEX P SPEEDSET BONE CEMENT | LOD | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| January 13, 2006 | K053528 | SHORT CITATION FEMORAL STEM | MEH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| December 27, 2005 | K052917 | STRYKER COMPARTMENTAL KNEE SYSTEM | NPJ | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| October 27, 2005 | K052718 | V40 BIOLOX DELTA CERAMIC FEMORAL HEADS | LZO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| October 12, 2005 | K051977 | SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| September 26, 2005 | K051741 | ACCOLADE HFX FEMORAL STEM | LZO | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 3, 2003 | P000013 | TRIDENT SYSTEM | MRA | 26 | September 17, 2025 | accessdata.fda.gov |
| June 13, 1997 | P960047 | OSTEONICS CONSTRAINED ACETABULAR INSERT | KWZ | 3 | July 25, 2001 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 226.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 16, 2026 | 99883 | Class II | Ongoing | TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization. | accessdata.fda.gov |
| July 30, 2026 | 99558 | Class II | Ongoing | AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene) | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms in | accessdata.fda.gov |
| May 19, 2026 | 99080 | Class II | Ongoing | TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB). | accessdata.fda.gov |
| February 2, 2026 | 98411 | Class II | Ongoing | MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 | A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment. | accessdata.fda.gov |
| November 12, 2025 | 97988 | Class II | Ongoing | The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which inc | When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device. | accessdata.fda.gov |
| August 28, 2025 | 97559 | Class II | Ongoing | 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352 | a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted. | accessdata.fda.gov |
| September 4, 2024 | 95315 | Class II | Ongoing | Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected fo | Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert. | accessdata.fda.gov |
| August 7, 2024 | 95277 | Class II | Ongoing | MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 | Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces. | accessdata.fda.gov |
| August 5, 2024 | 95114 | Class II | Ongoing | Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00 | A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal. | accessdata.fda.gov |
| June 19, 2024 | 94871 | Class II | Ongoing | UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043 | Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm) | accessdata.fda.gov |
| May 23, 2024 | 94708 | Class II | Ongoing | HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900 | The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments. | accessdata.fda.gov |
| February 27, 2024 | 94215 | Class II | Ongoing | TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | accessdata.fda.gov |
| February 6, 2024 | 94026 | Class II | Ongoing | X3 TRIATHLON CS INSERT NO 3 10 MM | Potential packaging breaches of inner blister and outer sterile blister. | accessdata.fda.gov |
| December 22, 2023 | 93830 | Class II | Ongoing | HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty | Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility | accessdata.fda.gov |
| December 1, 2023 | 93687 | Class II | Ongoing | SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026 | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | accessdata.fda.gov |
| May 3, 2023 | 92359 | Class II | Ongoing | Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026 | The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head. | accessdata.fda.gov |
| April 13, 2023 | 92257 | Class II | Ongoing | TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E | Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa | accessdata.fda.gov |
| March 10, 2023 | 91913 | Class II | Ongoing | stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure | Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking | accessdata.fda.gov |
| November 7, 2022 | 91147 | Class III | Ongoing | Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001 | Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate. | accessdata.fda.gov |
| October 21, 2022 | 91044 | Class II | Ongoing | Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010 | Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010) | accessdata.fda.gov |
| August 24, 2022 | 90836 | Class II | Ongoing | Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component. | A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing. | accessdata.fda.gov |
| March 30, 2022 | 90241 | Class II | Ongoing | Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon Tritanium Tibial Component (Size 5); Catalog Number 5536-B-500 | Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling. | accessdata.fda.gov |
| January 14, 2022 | 89592 | Class II | Ongoing | Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032 | Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling | accessdata.fda.gov |
| December 30, 2021 | 89520 | Class II | Terminated | Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044 | There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem. | accessdata.fda.gov |
| December 21, 2021 | 89456 | Class II | Ongoing | 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032 | There is a potential for the outer Tyvek lid to de-bond from the sealed package. | accessdata.fda.gov |
| November 24, 2021 | 89190 | Class II | Ongoing | Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System fo | Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation | accessdata.fda.gov |
| October 15, 2021 | 88964 | Class II | Ongoing | 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028 | XXX | accessdata.fda.gov |
| July 1, 2021 | 88422 | Class II | Terminated | Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700 | The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate. | accessdata.fda.gov |
| March 5, 2021 | 87517 | Class II | Terminated | Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer. Catalog Number: I-K3834CG00 S | The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Trial Cutting Guide packaging during transport or during impaction of the instrument in surgery. | accessdata.fda.gov |
| February 10, 2021 | 87350 | Class II | Terminated | Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer. | Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate. | accessdata.fda.gov |
| April 16, 2020 | 85583 | Class II | Terminated | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17) | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | accessdata.fda.gov |
| November 7, 2019 | 84346 | Class II | Terminated | Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254 | May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire | accessdata.fda.gov |
| October 3, 2019 | 84148 | Class II | Terminated | Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025 | Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015) | accessdata.fda.gov |
| August 19, 2019 | 83671 | Class II | Terminated | TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and | Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component | accessdata.fda.gov |
| September 10, 2018 | 81192 | Class II | Terminated | Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual | Potential for outer pouch sterile barrier to be compromised | accessdata.fda.gov |
| May 22, 2018 | 80059 | Class II | Terminated | LFIT Anatomic CoCr Femoral Heads, 6260-9-036 | The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011. | accessdata.fda.gov |
| January 30, 2018 | 79600 | Class II | Terminated | Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function. | Customers may receive the incorrect size implant from what is labeled on the box. | accessdata.fda.gov |
| January 12, 2018 | 79661 | Class II | Terminated | Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function | Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box. | accessdata.fda.gov |
| December 21, 2017 | 79485 | Class II | Terminated | Custom Made Implant System with Minimum Invasive Grower (MIG) component | From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to the locking screw. | accessdata.fda.gov |
| October 24, 2017 | 79315 | Class II | Terminated | Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. | accessdata.fda.gov |
| July 21, 2017 | 79038 | Class II | Terminated | Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737 | Inner and outer sterile barriers not fully sealed. | accessdata.fda.gov |
| April 26, 2017 | 77148 | Class II | Terminated | Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformit | Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended position on the Quick Release mechanism of the Transport Struts. | accessdata.fda.gov |
| December 2, 2016 | 75889 | Class II | Terminated | Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA S | Reunion TSA Peg Alignment Sound broke during surgery. | accessdata.fda.gov |
| November 9, 2016 | 75792 | Class II | Terminated | GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bon | A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error. | accessdata.fda.gov |
| August 29, 2016 | 75246 | Class II | Terminated | LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement. | Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads. | accessdata.fda.gov |
| August 18, 2016 | 75077 | Class II | Terminated | Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp. | Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner. | accessdata.fda.gov |
| August 1, 2016 | 75015 | Class II | Terminated | Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for the implantation of Sco | Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument. | accessdata.fda.gov |
| July 1, 2016 | 74743 | Class II | Terminated | Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by clos | Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle. | accessdata.fda.gov |
| June 30, 2016 | 74727 | Class II | Terminated | Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, | Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field. | accessdata.fda.gov |
| June 23, 2016 | 74634 | Class II | Terminated | Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (T | Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved potentially resulting in disassociation from the instrument. | accessdata.fda.gov |
| June 23, 2016 | 74619 | Class II | Terminated | Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extrem | It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size spe | accessdata.fda.gov |
| June 3, 2016 | 74500 | Class II | Terminated | Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty. | Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method. | accessdata.fda.gov |
| January 21, 2016 | 73156 | Class II | Terminated | Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments. | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | accessdata.fda.gov |
| December 23, 2015 | 73042 | Class II | Terminated | Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures. | The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instructions For Use (IFU) states the device are sterilized via gamma irradiation and should not be resterilized. Since the IFU states the devices are sterile, no instructions for moist heat sterilization are provided. | accessdata.fda.gov |
| October 15, 2015 | 72506 | Class II | Terminated | Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells a | Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the US, although the 22 mm size was inadvertently omitted from 510(k) #K963612. | accessdata.fda.gov |
| September 29, 2015 | 72381 | Class II | Terminated | Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capture for the distal f | Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints were received that specific lots of this product may disassociate during use. | accessdata.fda.gov |
| September 21, 2015 | 72498 | Class II | Terminated | Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial st | Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s). | accessdata.fda.gov |
| September 8, 2015 | 72297 | Class II | Terminated | Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component. | Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery. | accessdata.fda.gov |
| June 25, 2015 | 71754 | Class II | Terminated | Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component | it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field. | accessdata.fda.gov |
| June 24, 2015 | 71676 | Class II | Terminated | rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius. | Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation. | accessdata.fda.gov |
| May 29, 2015 | 71678 | Class II | Terminated | Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism. | Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209). | accessdata.fda.gov |
| May 29, 2015 | 71677 | Class II | Terminated | Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tib | Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert. | accessdata.fda.gov |
| May 12, 2015 | 71445 | Class II | Terminated | ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Ma | A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial. | accessdata.fda.gov |
| February 27, 2015 | 70784 | Class II | Terminated | Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (MRH), Scorpio Total St | Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 (Kinemax Stem Extenders, 80 mm) there was a different part #6476-8-250 (Kinemax Stem Extenders, 40 mm. | accessdata.fda.gov |
| February 12, 2015 | 70341 | Class II | Terminated | Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon p | Potential for weld disassociation of the cross pin, which could lead to loose or disassociated trigger mechanism on the Distal Capture Assembly. | accessdata.fda.gov |
| February 3, 2015 | 70338 | Class II | Terminated | LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty. | Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding V40 stem trunnion. | accessdata.fda.gov |
| December 15, 2014 | 70100 | Class II | Terminated | Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled | Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present. | accessdata.fda.gov |
| August 15, 2014 | 70994 | Class II | Terminated | Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. Hip prosthesis component. The RESTORATION Acetabular Wedge Augments p | The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier. | accessdata.fda.gov |
| July 24, 2014 | 69065 | Class II | Terminated | Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization o | Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label. | accessdata.fda.gov |
| May 1, 2014 | 68500 | Class II | Terminated | Stryker Orthopaedics Triathlon Tritanium Patella Inserter,. NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Pat | Tritanium Patella Inserter Instrument fracture during implantation.. | accessdata.fda.gov |
| February 3, 2014 | 67734 | Class II | Terminated | Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113, Left Size #4: catalog #6265-5104, and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hip Implants. | Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Size # 4 was identified in a packaging associated with a citation TMZF HA 132 degrees Neck Angle V40 Hip Stem - Right Size #3. | accessdata.fda.gov |
| December 6, 2013 | 67384 | Class II | Terminated | Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct tra | Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital. | accessdata.fda.gov |
| November 20, 2013 | 67234 | Class II | Terminated | Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Gree | Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle. | accessdata.fda.gov |
| November 7, 2013 | 67055 | Class II | Terminated | Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several | Stryker became aware during laboratory testing that there is a potential that the seal integrity of the outer pouch (sterile barrier) may be compromised for certain lots of the product Teflon Tube, sterile. | accessdata.fda.gov |
| October 25, 2013 | 66761 | Class II | Terminated | 1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # Stryker France ZAC Satolas Green Pusignan Av | Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5. | accessdata.fda.gov |
| October 10, 2013 | 73505 | Class II | Terminated | VariAx Compression Plating System | Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole. | accessdata.fda.gov |
| October 1, 2013 | 66908 | Class II | Terminated | Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone | Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm. | accessdata.fda.gov |
| September 30, 2013 | 66909 | Class II | Terminated | Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery. | Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments. | accessdata.fda.gov |
| July 8, 2013 | 65891 | Class II | Terminated | Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixati | Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect. | accessdata.fda.gov |
| July 2, 2013 | 65902 | Class II | Terminated | Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triat | Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument. | accessdata.fda.gov |
| May 21, 2013 | 65646 | Class II | Terminated | GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device intended for the temporary fixation, correction of stabilization | Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails. | accessdata.fda.gov |
| March 28, 2013 | 64942 | Class II | Terminated | Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proximal Tibia, and the Dist | Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Drill Bit 4.3,,X263mm, flat, manufactured by Stryker Osteosynthesis, is incorrect. The incorrect scale could result in the surgeon selecting a screw that is 10mm longer than intended. | accessdata.fda.gov |
| March 25, 2013 | 64941 | Class II | Terminated | Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France, ZAC Satolas Green Pusignan, Av de Satoles Green 6 | Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph of an acetabular shell rather than a femoral distal augment. In addition the label was missing a reference to the "10mm" augment thickness which per the label print is required to appear below the size | accessdata.fda.gov |
| February 23, 2013 | 64655 | Class II | Terminated | Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Gr | Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly. | accessdata.fda.gov |
| January 24, 2013 | 64456 | Class II | Terminated | Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE | The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed. | accessdata.fda.gov |
| December 20, 2012 | 64306 | Class II | Terminated | Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100 | Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use. | accessdata.fda.gov |
| November 8, 2012 | 64308 | Class I | Terminated | ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperativ | With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there are potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting Guides. | accessdata.fda.gov |
| October 25, 2012 | 63863 | Class II | Terminated | Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003. | Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients. | accessdata.fda.gov |
| October 23, 2012 | 61718 | Class II | Terminated | Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femo | Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix. | accessdata.fda.gov |
| August 17, 2012 | 63358 | Class II | Terminated | Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended | Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely, packaging associated with a 25mm screw may contain a 35mm screw. | accessdata.fda.gov |
| August 6, 2012 | 63457 | Class II | Terminated | Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube | During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube. | accessdata.fda.gov |
| July 27, 2012 | 63442 | Class II | Terminated | Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Sat | Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise; the Femoral Offset Bushing did not include rotational markings. | accessdata.fda.gov |
| July 16, 2012 | 63275 | Class II | Terminated | Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension piece is a component of the PAR assembly. The Peri-Acetabular Reconstruction (PAR) endoprosthesis w | Stryker has become aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem. | accessdata.fda.gov |
| July 3, 2012 | 63273 | Class II | Terminated | Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with | Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load bearing application by patients having a body weight greater than 250 LBS. | accessdata.fda.gov |
| April 30, 2012 | 62456 | Class II | Ongoing | ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 rig | Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and or corrosion at or about the modular neck junction. On June 29, 2012, Stryker has decided to remove the affected produc | accessdata.fda.gov |
| April 2, 2012 | 62594 | Class II | Terminated | Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone Body Trials simulate the respective Cone Body implants and mate with | Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portion of the Cone Body Trial. The typical size of the shaving observed was 1-2 mm in length and 0.037 mm squared in cross section. | accessdata.fda.gov |
| January 26, 2012 | 62051 | Class II | Terminated | Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. T | Stryker has become aware that there exists a potential for breach of the sterile barrier of packaging associated with certain lots of T2 Knee Arthrodesis Nails. | accessdata.fda.gov |
| December 29, 2011 | 62130 | Class II | Terminated | Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Single | Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use. | accessdata.fda.gov |
| December 29, 2011 | 61923 | Class II | Terminated | Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Sator | Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product. | accessdata.fda.gov |
| December 23, 2011 | 61715 | Not yet classified | Terminated | Cutting Edge Acetabular Spherical Reamer 44 M, Stryker Howmedica Osteonics Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA. The CuttingEdge acetabular reamers are used to ream the acetabulum and prepar | A 46mm acetabular reamer was lasermarked as a 44m reamer and distributed to the field. | accessdata.fda.gov |
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Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.