Data / Medical devices / United States / Depuy Orthopaedics, Inc.
Depuy Orthopaedics, Inc.: FDA-registered device maker in Warsaw, IN, United States, 294 510(k) clearances and 5 PMA approvals
Depuy Orthopaedics, Inc. is registered with the FDA (registration 1818910) in Warsaw, IN, United States. It lists 132 device types. The FDA files 294 510(k) clearances and 5 PMA approvals under its listings, the newest dated June 25, 2026. 86 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1818910
- Address
- 700 Orthopaedic DR., Warsaw, IN, United States, 46582
- Owner or operator
- DePuy Synthes, Inc. (1818910)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- December 22, 1977
- Registered through
- 2027
- Brand names listed
- ACCESSORY, ACE MARKIII ASSEMBLY, AMK (Knee), AMK (knee), AML ( hip), AML (hip), AML Hip, AML Hip Prosthesis 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 294.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 25, 2026 | K260480 | VELYS Robotic-Assisted Solution | OLO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| May 15, 2026 | K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | KWL | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| March 11, 2026 | K253624 | INHANCE Reverse Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| March 6, 2026 | K253551 | VELYS Hip Navigation | QIH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| January 22, 2025 | K243977 | EMPHASYS Acetabular System | LPH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| December 23, 2024 | K243248 | INHANCE INTACT | PKC | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| November 21, 2024 | K242871 | ATTUNE Revision Hinge Knee | KRO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| November 1, 2024 | K242665 | DePuy ATTUNE Total Knee System | OIY | Substantially Equivalent | Depuy Orthopedics, Inc. | accessdata.fda.gov |
| June 18, 2024 | K240678 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology | MBH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| June 14, 2024 | K233228 | Spine Navigation and Robotic-Assistance Device | OLO | Substantially Equivalent | Ecential Robotics | accessdata.fda.gov |
| June 5, 2024 | K240211 | VELYS Robotic-Assisted Solution | OLO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| April 4, 2024 | K240639 | PINNACLETM Constrained Acetabular Liners | KWZ | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| February 15, 2024 | K231522 | EMPHASYS Dual Mobility System | LPH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| January 19, 2024 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis MR Conditional | MEH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| December 14, 2023 | K233227 | VELYS Robotic-Assisted Solution | OLO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| December 11, 2023 | K232303 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology | MBH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| November 13, 2023 | K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | MBF | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| August 22, 2023 | K231503 | CUPTIMIZE Advanced | LLZ | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| July 21, 2023 | K231516 | INHANCE Shoulder System, Sterile Single Use Instrumentation | MBF | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| March 10, 2023 | K230295 | ATTUNE® Revision Cones | MBH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| January 6, 2023 | K222296 | ARTICUL/EZE Ceramic Heads | LZO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| December 2, 2022 | K223211 | INHANCETM Shoulder System Humeral Stems and Stemless | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| October 17, 2022 | K212746 | ATTUNE Revision Cones | MBH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| September 6, 2022 | K221636 | EMPHASYS Acetabular System | LPH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| August 31, 2022 | K221467 | INHANCETM Reverse Glenoid Peripheral Posts | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| June 8, 2022 | K212933 | INHANCETM Hybrid Anatomic Glenoid Implant | MBF | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| April 21, 2022 | K212737 | INHANCE Reverse Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| January 19, 2022 | K212683 | GLOBAL ICON Stemless Shoulder System | PKC | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| January 18, 2022 | K213781 | ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP | MBH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| January 6, 2022 | K213839 | DePuy Corail AMT Hip Prosthesis | LZO | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| September 15, 2021 | K212710 | GLOBAL UNITE Platform Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| August 25, 2021 | K211609 | ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert | JWH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| July 22, 2021 | K203694 | DELTA XTEND Reverse Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| July 16, 2021 | K203108 | Ignite Stemless Anatomic Shoulder System | PKC | Substantially Equivalent | Ignite Orthopedics, LLC | accessdata.fda.gov |
| May 20, 2021 | K210581 | Actis DuoFix Hip Prosthesis- Collarless | MEH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| May 20, 2021 | K202716 | Ignite Anatomic Shoulder System | MBF | Substantially Equivalent | Ignite Orthopedics, LLC | accessdata.fda.gov |
| April 2, 2021 | K203230 | Global Shoulder and Delta CTA systems | KWS | Substantially Equivalent | Depuy Lnc. | accessdata.fda.gov |
| February 26, 2021 | K203651 | Cuptimize | LLZ | Substantially Equivalent | Cuptimize, Inc. | accessdata.fda.gov |
| January 14, 2021 | K202769 | VELYS Robotic-Assisted Solution | OLO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| December 28, 2020 | K202248 | Attune Revision Sleeve LPS Femoral Adaptors | JWH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| November 25, 2020 | K202098 | GLOBAL UNITE Platform Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| October 21, 2020 | K202472 | ACTIS Duofix Hip Prosthesis | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| June 16, 2020 | K193540 | TRUMATCH Personalized Solutions | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 24, 2020 | K192855 | DELTA XTEND(TM) Reverse Shoulder System | PHX | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| February 4, 2020 | K193398 | Summit DuoFix HA Coating | MEH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 26, 2019 | K192919 | Pinnacle Duofix HA Acetabular Cup Prosthesis | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 8, 2019 | K182301 | PFC SIGMA Knee System | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 8, 2019 | K191779 | Attune Revision LPS Inserts | KRO | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| October 4, 2019 | K192448 | Delta Xtend Revers Shoulder System | PHX | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| May 17, 2019 | K183077 | Delta Xtend Reverse Shoulder System | PHX | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| April 26, 2018 | K170339 | Summit Hip System | LZO | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| January 11, 2018 | K170748 | GLOBAL UNITE Platform Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| August 3, 2016 | K160284 | JointPoint | LLZ | Substantially Equivalent | Jointpoint, Inc. | accessdata.fda.gov |
| July 19, 2016 | K160907 | DePuy Actis DuoFix Hip Prosthesis | MEH | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| June 10, 2016 | K160700 | ATTUNE Revision Knee System | JWH | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| September 25, 2015 | K150862 | DePuy Actis Duofox Hip Prosthesis | MEH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 13, 2015 | K140881 | DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS | MBH | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| April 3, 2014 | K133834 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | KWS | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| March 10, 2014 | K132959 | DEPUY PINNACLE ALTRX ACETABULAR LINERS | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| April 30, 2013 | K120599 | DEPUY M-SPEC 36MM FEMORAL HEADS | LPH | Substantially Equivalent | Depuy Orthopaedics | accessdata.fda.gov |
| March 1, 2013 | K123924 | DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS | LZO | Substantially Equivalent | Depuy Orthopaedics | accessdata.fda.gov |
| October 31, 2012 | K122395 | DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS | HSN | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| September 6, 2012 | K122442 | DEPUY CTA REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | Depuy France | accessdata.fda.gov |
| June 11, 2012 | K120174 | DEPUT DELTA XTEND REVERSE SHOULDER | PHX | Substantially Equivalent | Depuy France | accessdata.fda.gov |
| August 30, 2011 | K111433 | DEPUY STTUNE (TM) PS KNEE SYSTEM | OIY | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| August 16, 2011 | K110397 | TRUMATCH PERSONALIZED SOLUTIONS | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| March 15, 2011 | K103756 | DEPUY ATTUNE TOTAL KNEE SYSTEM | OIY | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 15, 2010 | K101996 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | PHX | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| December 10, 2010 | K101433 | DEPUY ATTUNE KNEE SYSTEM | OIY | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 23, 2010 | K102080 | DEPUY RECLAIM REVISION HIP SYSTEM | LZO | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| October 29, 2010 | K102423 | DEPUY PINNACLE ALTRX ACETABULAR LINERS | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| September 29, 2010 | K100391 | DEPUY UNIVERSAL GRIPTION TF CONES | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 17, 2009 | K093646 | DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| August 12, 2009 | K091453 | LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 | KRO | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| July 27, 2009 | K092122 | GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID | KWS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| July 14, 2009 | K091751 | DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP | KWS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| June 12, 2009 | K090998 | DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 9, 2009 | K083107 | MODIFICATION TO DEPUY NEUFLEX PIP FINGER | KYJ | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 18, 2008 | K082715 | DEPUY GLOBAL AP CTA HUMERAL HEAD | HSD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 4, 2008 | K082585 | DEPUY ASPHERE M-SPEC HEAD | KWA | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 18, 2008 | K082500 | DEPUY SIGMA CR-F FEMORAL COMPONENT | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| August 8, 2008 | K080990 | DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER | HSD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| June 30, 2008 | K081620 | MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM | KWS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 14, 2008 | K081163 | SMARTSET GMV GENTAMICIN BONE CEMENT | MBB | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 14, 2008 | K081155 | SMARTSET MV BONE CEMENT | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 21, 2008 | K073570 | DEPUY TRI-LOCK BONE PRESERVATION STEM | LZO | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| January 29, 2008 | K073676 | DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP | PHX | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| January 24, 2008 | K073529 | DEPUY SIGMA PS FEMORAL COMPONENTS | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| January 9, 2008 | K072963 | DEPUY PINNACLE ALTRX ACETABULAR LINERS | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 20, 2007 | K063686 | DEPUY LPS DISTAL FEMORAL COMPONENT | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 9, 2007 | K071059 | DEPUY SPA POROUS COATED PROXIMAL SLEEVE | KWZ | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| September 28, 2007 | K071830 | DEPUY DELTA TS CERAMIC FEMORAL HEADS | LZO | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| September 11, 2007 | K071379 | DELTA XTEND REVERSE SHOULDER MODULAR STEM | PHX | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| September 4, 2007 | K071016 | DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT | FTM | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| August 17, 2007 | K070267 | DEPUY GCK TIBIAL COMPONENTS | HRY | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| August 2, 2007 | K071417 | DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES | MBH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| July 25, 2007 | K071784 | DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| June 26, 2007 | K070849 | DEPUY GCK FEMORAL AND TIBIAL COMPONENTS | NPJ | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 23, 2007 | K071135 | DEPUY CI HIP INSTRUMENTATION | HAW | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 18, 2007 | K071117 | MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS | KWZ | Substantially Equivalent | DePuy Orthopaedics, Inc. | 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 |
|---|---|---|---|---|---|---|
| June 13, 2011 | P090002 | PINNACLE COMPLETE ACETABULAR HIP SYSTEM | OVO | 8 | August 6, 2013 | accessdata.fda.gov |
| December 23, 2010 | P070026 | CERAMAX CERAMIC HIP SYSTEM | MRA | 121 | September 4, 2026 | accessdata.fda.gov |
| June 19, 1997 | P960054 | S-ROM POLY-DIAL CONSTRAINED LINER | KWZ | 3 | December 22, 1999 | accessdata.fda.gov |
| October 30, 1992 | P910016 | NEW JERSEY LCS(R) TOTAL KNEE SYSTEM | NRA | 13 | December 12, 2005 | accessdata.fda.gov |
| April 12, 1985 | P830055 | LCS(R) TOTAL KNEE SYSTEM | NJL | 355 | October 9, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 12, 2024 | 94222 | Class II | Ongoing | ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System. | Product incorrectly labelled. | accessdata.fda.gov |
| February 15, 2023 | 91752 | Class II | Ongoing | Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118 | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties. | accessdata.fda.gov |
| June 29, 2022 | 90557 | Class II | Ongoing | ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525 | Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain | accessdata.fda.gov |
| May 18, 2022 | 90476 | Class II | Ongoing | MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 1363 | The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should be taken into consideration when using a Cathcart head in a construct for hemi-hip arthroplasty procedures. | accessdata.fda.gov |
| March 11, 2022 | 89959 | Class II | Terminated | VELYS Robotic-Assisted Solution Base Product No.: 451570100 | System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment | accessdata.fda.gov |
| January 5, 2022 | 89454 | Class II | Terminated | ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003 | May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur. | accessdata.fda.gov |
| December 7, 2021 | 89240 | Class II | Terminated | GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610 | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage | accessdata.fda.gov |
| September 9, 2021 | 88722 | Class II | Terminated | ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001 | Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery | accessdata.fda.gov |
| August 10, 2021 | 88522 | Class II | Terminated | TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment. | accessdata.fda.gov |
| July 1, 2021 | 88413 | Class II | Terminated | ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080 | Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement | accessdata.fda.gov |
| May 7, 2021 | 87975 | Class II | Terminated | DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR | Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product. | accessdata.fda.gov |
| February 22, 2021 | 87433 | Class II | Terminated | ATTUNE FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal i | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications. | accessdata.fda.gov |
| January 8, 2021 | 87189 | Class II | Terminated | Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products. | The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots. | accessdata.fda.gov |
| December 15, 2020 | 86946 | Class II | Terminated | Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 12 | Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally as a result of "cross-threading". If cross-threading occurs, physicians will not feel the positive stop of the Apex HE against the cup. | accessdata.fda.gov |
| January 3, 2020 | 84714 | Class II | Terminated | SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block. | The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery. | accessdata.fda.gov |
| September 21, 2018 | 82353 | Class II | Terminated | CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty. | There is the potential for debris/material to be found behind the O-rings in the neck trials. | accessdata.fda.gov |
| July 18, 2018 | 80666 | Class II | Terminated | P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830 | This unit may be missing the screw/collet Assembly | accessdata.fda.gov |
| June 21, 2018 | 80240 | Class II | Terminated | CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511 | Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures. | accessdata.fda.gov |
| April 16, 2018 | 79818 | Class II | Terminated | ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee | There may be burrs on the extraction hole threads. | accessdata.fda.gov |
| December 21, 2017 | 79475 | Class II | Terminated | (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemente | The SIGMA HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market surveillance process. | accessdata.fda.gov |
| November 28, 2017 | 79257 | Class II | Terminated | The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LEO-1100-30-000 REV D.pdf.pdf, LEO-1100-40-000 REV D.pdf.pdf, LEO | The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgical delays. | accessdata.fda.gov |
| August 31, 2017 | 79115 | Class II | Terminated | DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA comp | The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay. | accessdata.fda.gov |
| July 12, 2017 | 79024 | Class II | Terminated | CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 | Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130). | accessdata.fda.gov |
| January 6, 2017 | 76023 | Class II | Terminated | DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures | Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured. | accessdata.fda.gov |
| November 8, 2016 | 75608 | Class II | Terminated | LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery | DePuy Orthopaedics, Inc. is voluntarily recalling one lot of the LCS Complete Knee Revision System VVC Insert Small 22.5mm, due to the insert being manufactured outside of specifications, which prevents the insert from properly seating in the mating tibial tray. | accessdata.fda.gov |
| October 25, 2016 | 75540 | Class II | Terminated | ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU | DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient. | accessdata.fda.gov |
| January 8, 2016 | 73076 | Class II | Terminated | SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction. | Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin. Surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space. Insert Dislocation or Spin Out, or Poor Joint Mechanics may result, if not noted during | accessdata.fda.gov |
| September 8, 2015 | 72113 | Class II | Terminated | Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C. SIGMA knee procedures to align the femoral locating device a | DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to complaints of the rod fracturing and leaving a portion of the rod in patients. | accessdata.fda.gov |
| June 12, 2015 | 71421 | Class II | Terminated | ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attache | Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disass | accessdata.fda.gov |
| March 4, 2015 | 71085 | Class II | Terminated | LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery. | The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS COMPLETE RPS Knee System is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure. | accessdata.fda.gov |
| February 23, 2015 | 70692 | Class II | Terminated | RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation. | This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery and there is the potential for plastic pieces to be left in the patient. | accessdata.fda.gov |
| February 11, 2015 | 70507 | Class II | Terminated | SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedure | One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated. This may result in surgical delays while a replacement package of cement is retrieved and mixed. | accessdata.fda.gov |
| November 12, 2014 | 70046 | Class II | Terminated | I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical a | Use of excessive force when impacting may lead to intra-operative femoral fracture. | accessdata.fda.gov |
| November 10, 2014 | 70043 | Class II | Terminated | Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical | ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient. | accessdata.fda.gov |
| November 10, 2014 | 70014 | Class II | Terminated | The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fi | Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during impaction. If the lever fractures, there is the potential for fractured pieces of the device, or the inner spring, if released, to be left in the patient if not observed during surgery. | accessdata.fda.gov |
| November 7, 2014 | 69984 | Class II | Terminated | Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery. | Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosening refers to tissue tension and not the taper connection between the femoral head and stem. The investigations found that the small size sleeve (+1.5 femoral h | accessdata.fda.gov |
| October 15, 2014 | 69271 | Class II | Terminated | ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag | Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the plastic around the pin bushing. | accessdata.fda.gov |
| September 3, 2014 | 69104 | Class II | Terminated | RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal. | Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient. | accessdata.fda.gov |
| August 27, 2014 | 69052 | Class II | Terminated | Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incis | The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin. | accessdata.fda.gov |
| June 3, 2014 | 68440 | Class II | Terminated | RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation. | The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming. | accessdata.fda.gov |
| March 28, 2014 | 67691 | Class II | Terminated | GLOBAL Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product Usage: Usage: The GLOBAL APG+ 2.5mm Guide Pin is a single-use instrument that is used to a | Urgent Device Correction notifications are being sent to USA distributors with follow-up to surgeons concerning updated surgical techniques stressing the possibility of the shoulder pin guide breaking and potentially being left in the patient. | accessdata.fda.gov |
| February 24, 2014 | 67627 | Class II | Terminated | REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone los | DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in | accessdata.fda.gov |
| December 9, 2013 | 67159 | Class II | Terminated | PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility. | Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants to fracture under what would normally be acceptable loads. | accessdata.fda.gov |
| November 18, 2013 | 66864 | Class II | Terminated | SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total kn | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. | accessdata.fda.gov |
| September 16, 2013 | 66248 | Class II | Terminated | SmartSet Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, cont | The SmartSet GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the US FDA. The intended use stated in the IFU for the SmartSet GMV Endurance Gentamicin Bone Cement is for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentam | accessdata.fda.gov |
| July 11, 2013 | 65591 | Class I | Terminated | LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur. | The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads. | accessdata.fda.gov |
| May 8, 2013 | 65078 | Class III | Terminated | DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique. | LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove packages were mispackaged, with right handed, large sized glove packaging containing left handed, large sized gloves. | accessdata.fda.gov |
| May 3, 2013 | 65081 | Class II | Terminated | DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere. | The Glenosphere Orientation Guide Instrument Used with the Delta XTEND Reverse Shoulder is being recalled because an arrow that is etched on the instrument was incorrectly placed on the opposite side of the instrument. Using the improperly etched arrow as a guide could potentially lead to incorrect orientation of the glenosphere implant. | accessdata.fda.gov |
| February 25, 2013 | 64285 | Class II | Terminated | ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tiss | The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient. Once the root cause is determined and a design change is implemented, DePuy will conduct a formal swap-ou | accessdata.fda.gov |
| February 5, 2013 | 63973 | Class II | Terminated | Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Re | Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure. | accessdata.fda.gov |
| January 4, 2013 | 63783 | Class I | Terminated | LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. | DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities b | accessdata.fda.gov |
| December 3, 2012 | 63545 | Class II | Terminated | SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radi | accessdata.fda.gov |
| November 28, 2012 | 62764 | Class II | Terminated | Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This package is placed into a paperboard carton, labeled and shri | DePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle Cancellous Screw due to an incorrect description on the label. The label description reads Pinnacle Cannulated Screw and should read Pinnacle Cancellous Screw. | accessdata.fda.gov |
| August 22, 2012 | 62765 | Class II | Terminated | S-Rom Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon | Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner because the Carton label has an Incorrect Color Code Series Designation. We have received one complaint regarding this issue. | accessdata.fda.gov |
| July 31, 2012 | 62766 | Class II | Terminated | DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was dependant on the geometry of the product Product Usage: Description: Devices meeting the regulatory definition of a custom medical | In connection with a Warning Letter received from the U.S. Food & Drug Administration on December 9, 2011, DePuy Orthopaedics is taking steps to retrieve custom device implants that surgeons may have ordered from DePuy Orthopaedics, but not implanted. DePuy Orthopaedics received a Warning Letter from the FDA on December 9, 2011 regarding custom device implan | accessdata.fda.gov |
| July 24, 2012 | 62649 | Class II | Terminated | Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Pa | In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. This resulted in a size 52 liner being etched and labeled as a size 54 liner. | accessdata.fda.gov |
| May 16, 2012 | 61749 | Class II | Terminated | ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemen | accessdata.fda.gov |
| March 16, 2012 | 61304 | Not yet classified | Terminated | DePuy Attune Impaction Handle Warsaw, IN 46582 Packaging: Product is packed within a polyethylene bag, with protection added as needed for sharp and/or fragile points. Product Usage: The ATTUNE Impaction handle is intend | DePuy Orthopaedics, Inc. is issuing a Recall Notice for nine lots of the Attune" Impaction Handle due to the potential for the handle trigger to break during surgery. The Attune Impactor is provided as a part of a set of tools and is designed specifically for the installation of the Attune Knee | accessdata.fda.gov |
| March 12, 2012 | 61342 | Not yet classified | Terminated | PFC Steinman Pin/Drill Pack Sterile (WPC ) Drill Bit and Steinman Pin Packet (1 unit) The PFC Steinman Pin/Drill Pack Sterile is part of the PFC Modular Knee Instrument system. The single pack (1 box) contains 2 pieces o | Sterility of the pins is at risk because product packaging, which is designed to include 2 pouches (inner pouch and outer pouch) around the pin mounting card only, contains a single pouch, which could compromise product sterility. | accessdata.fda.gov |
| March 7, 2012 | 61315 | Class II | Terminated | Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patien | DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner because the product was incorrectly labeled on the box. The box was labeled for a 36IDX52OD +4 Neutral Liner, but the product enclosed was a 36IDX56OD Neutral Liner. Three ( 3 ) complaints were received in January 2012. | accessdata.fda.gov |
| December 13, 2011 | 60320 | Not yet classified | Terminated | The SIGMA HP Fixed Bearing Tibial Tray Impactor is part of a set of tools designed specifically for the installation of the PFC SIGMA Knee. SIGMA HP Fixed Bearing Tibial Tray Impactors Packaged in poly bag with optional | All lots of DePuy, SIGMA HP Fixed Bearing Tibial Tray Impactors are being recalled because the impactor can become intentionally locked on the Tibial Tray implant during surgery. | accessdata.fda.gov |
| November 8, 2011 | 60325 | Not yet classified | Terminated | Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy Ace-Fischer External Fixation System and are packaged in a flexible polyethylene bag. | DePuy has received three complaints concerning oversized bolt threads in the Offset Wire Fixation Bolts used in the Ace- Fischer External Fixation System. This could lead to the inability to properly thread the nut onto the bolt. | accessdata.fda.gov |
| June 28, 2011 | 59238 | Not yet classified | Terminated | PFC Sigma Round Dome Patella 38 MM 3 Peg Device is indicated for use in knee replacement procedures in conjunction with femoral knee prosthesis components and polymethylmethacrylate (PMMA) bone cement. | DePuy initiated a voluntary recall effective immediately, for one lot of P.F.C. SIGMA RD Dome Patella 3 Peg (38mm) due to packaging labels that did not correctly reflect the size of the enclosed patellar component. In the recalled lot, the packaging is labeled for a P.F.C. SIGMA 38mm 3 peg Round Dome Patella, but the product enclosed in the package is a P.F. | accessdata.fda.gov |
| January 27, 2011 | 57900 | Not yet classified | Terminated | DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 1, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip p | The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compromised, the sterility of the inner pouch containing the product cannot be assured. Lack of sterility of the inner pouch could potentially cause contamination of the sterile field, including the implan | accessdata.fda.gov |
| January 12, 2011 | 57916 | Not yet classified | Terminated | AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile, DePuy Orthopaedics, Inc., Warsaw, IN; DePuy International Leeds, England. | The firm recieved a complaint that the cannula for the drill is not the same size at both ends. The drill is grabbing the guidewire and advancing and not allowing to finish reaming, resulting in the possibility of the guide wire progressing through and penetrating the acetabulum. | accessdata.fda.gov |
| November 1, 2010 | 57396 | Not yet classified | Terminated | PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 6 hole, Sterile, REF 8141-30-106, Depuy Orthopaedics, Inc.Warsaw, IN. | The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock with the plate, instead the screw passes through the plate. | accessdata.fda.gov |
| October 19, 2010 | 57245 | Not yet classified | Terminated | S-ROM Distal Femoral Cutting block Guide SZ X- SM/SM, REF 216311001, non-sterile, Depuy International Leeds, England. The product is used to make cuts in the femur to prepare the femur for total knee replacement surgery. | The firm was notified that the Hinge Block Femoral Box Guide cut being off alignment when using the S-ROM Distal Femoral Cutting Block Guide SZ SML/X-SML pin holes to locate. The firm then found that the same issue was found int the MED block size. | accessdata.fda.gov |
| August 23, 2010 | 57177 | Not yet classified | Terminated | ASR ACETABULAR IMPLANT 44, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipola | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2 | accessdata.fda.gov |
| June 15, 2010 | 56026 | Not yet classified | Terminated | Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The | Firm discovered that some of their straight broach handles are experiencing early failure due to a weakened handle locking mechanism (Leaf Spring). | accessdata.fda.gov |
| March 5, 2010 | 55575 | Not yet classified | Terminated | DePuy ASR 100 Acetabular Implant, 50 mm, 999800750, sterile, DePuy International, Ltd, Leeds, United Kingdom. | Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical re | accessdata.fda.gov |
| May 7, 2009 | 52088 | Not yet classified | Terminated | DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, Inc., Warsaw, IN; REF 96-0005. The device is used for total or unicompartmental k | There may be a crack on the lateral side of the condyle in the posterior chamfer region. The device is used as a Orthopedic knee implant. | accessdata.fda.gov |
| December 23, 2008 | 50700 | Not yet classified | Terminated | DePuy DNP Anatomic Fracture Repair System, Locking Screw DNP Anatomic, Depuy, Warsaw, IN; REF DNPALS. The device is used in the treatment of fractures and osteotomies of the distal radius. | The DNP nail plate may not attach to the alignment guide (jig) instrument, making it difficult to insert the nail plate into position or to drill needed holes accurately. | accessdata.fda.gov |
| July 10, 2008 | 49112 | Not yet classified | Terminated | Depuy DELTA Xtend, Standard humeral PE Cup Dia 38/+3 STD, sterile, Depuy France; REF 130738203. The device is used as a shoulder implant. | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. | accessdata.fda.gov |
| May 6, 2008 | 48089 | Not yet classified | Terminated | Depuy LCS Knee - Orthopedic knee implant. Meniscal bearing insert, Sz: STD, mm thick 12 5, sterile; Depuy Orthopaedics, Inc., Warsaw, IN; REF 1178-21-025). Product is a prosthesis, knee, patellofemorotibial, semi-constra | Labeling Discrepancy -- Mislabeled and mis-etched as to size. Inserts were labeled and packaged as size Standard, 12.5mm Inserts but were actually a 10mm Inserts. Risks include but not limited to: a delay in the procedure while the proper component is located, and tight joint with constricted movement as a result of implantation of the wrong thickness of ins | accessdata.fda.gov |
| October 30, 2007 | 45478 | Not yet classified | Terminated | Depuy TK2 Compression Hip Screw trauma plate, Standard Barrel,135 Degree, 4H-92.6mm, sterile; REF 8315-35-004, DePuy Orthopaedics, Inc., Warsaw, IN 46581 | Mis-etched/labeled as to barrel length: the lot with the short barrel was etched and labeled as a standard barrel and the lot with the standard barrel was etched and labeled as a short barrel. | accessdata.fda.gov |
| September 27, 2007 | 44893 | Not yet classified | Terminated | Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 8.0 mm, 2.5, sterile; Product Code/REF 96-0430. | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | accessdata.fda.gov |
| July 13, 2007 | 38464 | Not yet classified | Terminated | SmartSeal Wedge Femoral Pressuriser; Product Code/Catalog No: 3206002, DePuy Orthopaedics, Inc., 700 Orthopaedics Drive, Warsaw, Indiana 46581-0988-This product allows for effective and controlled pressurization of bone | Package Integrity: The outer peelable pouch seals may be compromised due to creasing, although the inner pouch seals are intact. | accessdata.fda.gov |
| November 15, 2006 | 36849 | Not yet classified | Terminated | Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 1, sterile; Part number 1498-24-001. | Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect. | accessdata.fda.gov |
| September 14, 2006 | 36348 | Not yet classified | Terminated | Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100. | Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella. | accessdata.fda.gov |
| November 8, 2005 | 34018 | Not yet classified | Terminated | Depuy brand Acclaim Elbow linked ulnar bearing, sterile; catalog # 1722-60-000. | The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary. | accessdata.fda.gov |
| June 7, 2005 | 32282 | Not yet classified | Terminated | Depuy brand LCS Complete metal backed patella, porocoat, STD; REF 1294-09-640. | There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition. | accessdata.fda.gov |
| May 26, 2005 | 32192 | Not yet classified | Terminated | Depuy LCS Complete RP insert; polyethylene tibial insert SM+, 10 mm; Ref 1294-05-210. | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | accessdata.fda.gov |
| January 15, 2004 | 29309 | Not yet classified | Terminated | P.F.C. Modular Knee System Modular Plus Tibial Wedge 10 HEMI x 8.5MM HEIGHT Product Code: 86-0178 | Screw size included in system was incorrect | accessdata.fda.gov |
| December 22, 2003 | 29314 | Not yet classified | Terminated | P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703 | The collar was incorrectly etched for the R (right) and L (Left) orientation | accessdata.fda.gov |
| December 11, 2003 | 27923 | Not yet classified | Terminated | Depuy brand ACE trochanteric nail; sterile, long, left hip, 320 x 11 x 130; Product 925200320. | The lag screw may migrate to the femoral head or into the abdominal cavity. | accessdata.fda.gov |
| June 27, 2003 | 26691 | Not yet classified | Terminated | ProVision Hytrel Elastomer Hood; product 5431-05-000. | Lack of assurance of sterility, due to the possibility of an incomplete package seal. | accessdata.fda.gov |
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Updated June 25, 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.