Data / Medical devices / Switzerland / STRYKER GmbH
STRYKER GmbH: FDA-registered device maker in SELZACH Solothurn, Switzerland, 225 510(k) clearances and 1 PMA approval
STRYKER GmbH is registered with the FDA (registration 8031020) in SELZACH Solothurn, Switzerland. It lists 61 device types. The FDA files 225 510(k) clearances and 1 PMA approval under its listings, the newest dated June 29, 2026. 21 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8031020
- FEI number
- 3002807830
- Address
- Bohnackerweg 1, SELZACH Solothurn, Switzerland, 2545
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- December 29, 1977
- Registered through
- 2027
- Brand names listed
- 045 IN. (1.143mm) K-WIRE W/LENGTH MARKINGS, 1.2X10mm BONE SCREWSCROSSPINSELFT, 1.2X12mm BONE SCREWSCROSSPINSELFT, 1.2X14mm BONE SCREWSCROSSPINSELFT, 1.2X16mm BONE SCREWSCROSSPINSELFT, 1.2X18mm BONE SCREWSCROSSPINSELFT, 1.2X20mm BONE SCREWSCROSSPINSELFT, 1.2X4mm BONE SCREWSCROSSPINSELFT 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 225.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 29, 2026 | K261481 | Pangea Femur Reconstruction System | HSB | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| February 3, 2026 | K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | HSB | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| December 19, 2025 | K253202 | Hoffmann LRF System | KTT | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| August 20, 2025 | K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | HSB | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| August 13, 2025 | K250163 | T2 Alpha Femur Retrograde Nailing System | HSB | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| October 6, 2024 | K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| March 25, 2024 | K233919 | VariAx 2 Distal Radius System | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| December 21, 2023 | K233741 | Hoffmann LRF System | KTT | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| August 18, 2023 | K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| August 18, 2023 | K231257 | Pangea Utility Plating System, Pangea Platform | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| June 9, 2023 | K230512 | Gamma4 System | HSB | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| April 27, 2023 | K222381 | PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| April 7, 2023 | K223772 | PRO Plating System, Stryker Trauma Pelvic Set (Matta) | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| November 15, 2022 | K222309 | Gamma4 System | HSB | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| July 8, 2022 | K221346 | Stryker VariAx 2 MIS Calcaneus | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| June 10, 2022 | K220319 | Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System | HWC | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| June 10, 2022 | K210582 | EasyClip® and EasyClip® Xpress | JDR | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| February 11, 2022 | K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System | HSB | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| January 19, 2022 | K212581 | VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| January 11, 2022 | K213199 | Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System | HWC | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| October 5, 2021 | K211508 | Steinmann Pins and Kirschner Wires | JDW | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| September 3, 2021 | K210861 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | KWS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| February 26, 2021 | K203819 | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System | HSB | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| December 18, 2020 | K202749 | ADAPT for Gamma3 | OLO | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| December 16, 2020 | K202289 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | KWS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| July 22, 2020 | K200869 | Gamma3 System | HSB | Substantially Equivalent | Stryker Trauma GmbH | accessdata.fda.gov |
| June 5, 2020 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| March 20, 2020 | K193366 | T2 ICF | HWC | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| February 23, 2020 | K193308 | T2 Alpha Tibia Nailing System, IMN Screws System | HSB | Substantially Equivalent | Stryker Trauma GmbH | accessdata.fda.gov |
| November 22, 2019 | K192675 | VariAx Foot | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| August 23, 2019 | K191412 | VariAx 2 System, VariAx 2 Mini Fragment System | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| June 11, 2019 | K191271 | T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System | HSB | Substantially Equivalent | Stryker Trauma GmbH | accessdata.fda.gov |
| February 15, 2019 | K183039 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | KWS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| October 12, 2018 | K181848 | ADAPT for Gamma3, Gamma3 | OLO | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| October 11, 2018 | K181091 | AxSOS 3 Ti | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| June 6, 2018 | K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System | HSB | Substantially Equivalent | Stryker Trauma GmbH | accessdata.fda.gov |
| June 4, 2018 | K180500 | VariAx 2 System | HWC | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| May 2, 2018 | K173946 | ADAPT for Gamma3 | OLO | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| January 12, 2018 | K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System | HSB | Substantially Equivalent | Stryker Trauma GmbH | accessdata.fda.gov |
| December 15, 2017 | K172350 | AxSOS 3 Ti | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| October 2, 2017 | K172210 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | KWS | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| June 22, 2017 | K170727 | VariAx 2 Compression Plating System | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| June 20, 2017 | K170418 | Stryker SonicPin System | HTY | Substantially Equivalent | Stryker Trauma GmbH | accessdata.fda.gov |
| May 8, 2017 | K170771 | VariAx 2 Foot System | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| April 14, 2017 | K163656 | Hoffmann LRF System | KTT | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| February 21, 2017 | K162841 | VariAx Distal Radius Plating System, VariAx 2 System | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| February 10, 2017 | K162321 | EasyClip Xpress | JDR | Substantially Equivalent | Restore Surgical, LLC Dba Instratek | accessdata.fda.gov |
| February 3, 2017 | K162439 | AxSOS 3 Ti; Stryker Plating System | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| November 23, 2016 | K161863 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) | KWS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| November 22, 2016 | K161778 | ToeTac 10° Hammertoe Fixation System | HWC | Substantially Equivalent | Restore Surgical, LLC Dba Instratek | accessdata.fda.gov |
| July 26, 2016 | K160813 | EasyStep | JDR | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| April 11, 2016 | K153377 | Hoffmann LRF (Limb Reconstruction Frame) System | KTT | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| December 28, 2015 | K153154 | Asnis JFX System | HWC | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| October 27, 2015 | K151769 | Anchorage 2 CP System | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| August 6, 2015 | K151879 | VariAx 2 One-Third Tubular Plating System | HRS | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| June 24, 2015 | K151178 | VariAx 2 Wrist Fusion System | HRS | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| June 4, 2015 | K150443 | ToeTac Hammertoe Fixation System | HWC | Substantially Equivalent | Restore Surgical, LLC Dba Instratek | accessdata.fda.gov |
| December 22, 2014 | K143138 | AxSOS 3 Ti Locking Plate System | HRS | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| November 10, 2014 | K140961 | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM | KTT | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| August 7, 2014 | K141992 | VARIAX 2 SYSTEM | HRS | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| July 22, 2014 | K141677 | VARIAX ELBOW PLATING SYSTEM | HRS | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| July 18, 2014 | K141430 | VARIAX DISTAL RADIUS PLATING SYSTEM | HRS | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| June 20, 2014 | K141204 | VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM | HRS | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| June 20, 2014 | K141121 | AXSOS 3 TI LOCKING PLATE SYSTEM | HRS | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| April 3, 2014 | K140376 | VARIAX 2 SYSTEM | HRS | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| April 1, 2014 | K140259 | VARIAX CLAVICLE HOOK PLATE | HRS | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| March 24, 2014 | K133974 | VARIAX DISTAL RADIUS PLATING SYSTEM | HRS | Substantially Equivalent | Stryker Leibinger GmbH | accessdata.fda.gov |
| February 28, 2014 | K133451 | FIXOS SCREW SYSTEM | HWC | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| December 27, 2013 | K130895 | REUNION RSA SHOULDER SYSTEM | PHX | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| December 18, 2013 | K133440 | AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION | HWC | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| October 23, 2013 | K132502 | VARIAX 2 SYSTEM | HRS | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| October 10, 2013 | K131365 | T2 TIBIAL NAILING SYSTEM | HSB | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| June 10, 2013 | K130907 | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM | KTT | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| May 31, 2013 | K131132 | PELVIS II IMPLANT SYSTEM | HRS | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| May 3, 2013 | K130147 | ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL) | HSB | Substantially Equivalent | Small Bone Innovations, Inc. | accessdata.fda.gov |
| March 28, 2013 | K123964 | AXSOS 3 TI LOCKING PLATE SYSTEM | HRS | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| March 22, 2013 | K130009 | VARIAX 2 COMPRESSION PLATING SYSTEM | HRS | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| March 20, 2013 | K123403 | AXSOS PROXIMAL LATERAL TIBIA LONG PLATES | HRS | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| March 12, 2013 | K122113 | MEMORY METAL STAPLES, EASYCLIP | JDR | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| March 5, 2013 | K130116 | SUPERIOR LATERAL VARIAX CLAVICLE PLATE | HRS | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| January 23, 2013 | K123401 | GAMMA3 AND T2 RECON TARGETING DEVICES | HSB | Substantially Equivalent | Stryker Trauma AG | accessdata.fda.gov |
| October 24, 2012 | K122284 | HOFFMANN 3 | KTT | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| October 1, 2012 | K122308 | AXSOS DISTAL LATERAL FEMUR TS LONG PLATES | HRS | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| July 25, 2012 | K121252 | HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| May 17, 2012 | K120493 | MINI CANNULATED HEADED AND HEADLESS SCREW SET | HWC | Substantially Equivalent | Instratek, Inc. | accessdata.fda.gov |
| April 25, 2012 | K113760 | VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK | HRS | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| April 2, 2012 | K112982 | ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ) | HSB | Substantially Equivalent | Small Bone Innovations, Inc. | accessdata.fda.gov |
| March 29, 2012 | K113327 | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM | KTT | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| February 15, 2012 | K113409 | S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL | HSB | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| January 26, 2012 | K111786 | HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| November 17, 2011 | K112197 | MEMOMETAL INTRA-MEDULLARY BONE FASTENER | HTY | Substantially Equivalent | Memometal Technologies | accessdata.fda.gov |
| September 22, 2011 | K112455 | AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES | HRS | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| August 31, 2011 | K111032 | CMC CABLE FIX | HTN | Substantially Equivalent | Instratek, Inc. | accessdata.fda.gov |
| May 5, 2011 | K103835 | REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N | KWS | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 18, 2011 | K110476 | AXSOS (TM) LOCKING PLATE SYSTEM | HRS | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| February 15, 2011 | K110176 | AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS | HRS | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| January 14, 2011 | K102885 | HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX | JEC | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| December 22, 2010 | K102992 | T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES | HSB | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| December 20, 2010 | K102180 | RHEAD RADIAL HEAD EXTENDED STEMS | JDB | Substantially Equivalent | Small Bone Innovations, Inc. | accessdata.fda.gov |
| December 7, 2010 | K102282 | THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES | HRS | Substantially Equivalent | Howmedica Osteonics Corp., Dba 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 |
|---|---|---|---|---|---|---|
| June 19, 1997 | P960053 | BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS | KWG | 5 | August 9, 2016 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 1, 2026 | 99246 | Class II | Ongoing | Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | accessdata.fda.gov |
| May 28, 2025 | 96927 | Class II | Ongoing | Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S. | Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail. | accessdata.fda.gov |
| May 22, 2025 | 96924 | Class II | Ongoing | Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S. | Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail. | accessdata.fda.gov |
| March 28, 2025 | 96555 | Class II | Ongoing | Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S | The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery. | accessdata.fda.gov |
| May 9, 2024 | 94721 | Class II | Ongoing | Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System. | The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly. | accessdata.fda.gov |
| February 7, 2023 | 91666 | Class II | Ongoing | stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved | Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked between 0- 50mm of the threaded rod. | accessdata.fda.gov |
| March 28, 2022 | 89861 | Class II | Ongoing | Smart Toe II Intramedullary Arthrodesis Implant | The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity". | accessdata.fda.gov |
| May 27, 2021 | 88240 | Class II | Ongoing | Nail Insertion Sleeve, elastic T2 Tibia SPI 8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S | The devices have a different inner diameter than the diameter specified on the outer box label. | accessdata.fda.gov |
| September 25, 2020 | 86597 | Class II | Ongoing | Osteosynthesis Compression Staple EasyClip | The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used. | accessdata.fda.gov |
| May 7, 2020 | 85681 | Class II | Terminated | Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones. | Seal integrity of the blister pack may be compromised and sterility cannot be assured | accessdata.fda.gov |
| December 5, 2019 | 84458 | Class II | Terminated | Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of nails through the Targeting Device Catalog Number: 2351-0050 | Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal. | accessdata.fda.gov |
| November 21, 2019 | 84451 | Class II | Terminated | Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fr | Pin To Rod Coupling could not clamp the pin and rod as intended | accessdata.fda.gov |
| July 25, 2019 | 83423 | Class II | Terminated | Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The E | The seal integrity of the sterile bag containing the kits may be compromised. | accessdata.fda.gov |
| April 30, 2019 | 82894 | Class II | Terminated | Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1 | The seal integrity of the sterile bag containing the kits may be compromised. | accessdata.fda.gov |
| January 21, 2019 | 82140 | Class II | Terminated | Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty | The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set. | accessdata.fda.gov |
| August 28, 2018 | 81087 | Class II | Terminated | Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractur | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured. | accessdata.fda.gov |
| July 26, 2018 | 80863 | Class II | Terminated | Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002 | When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3, or 4), the Hexapod Software computes an erroneously accelerated correction plan for the axial portion of the plan. | accessdata.fda.gov |
| June 27, 2018 | 80613 | Class II | Terminated | Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S T2 LONG PROXIMAL HUMERAL NAIL LEFT 280mm | Incomplete seal on the Tyvek lid may compromise the sterility of the device | accessdata.fda.gov |
| May 4, 2018 | 80198 | Class II | Terminated | Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463 | Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm | accessdata.fda.gov |
| April 27, 2018 | 80131 | Class II | Terminated | Tibial Nail, Standard T2 Tibia 12x315 mm, Product Number 18221231S | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | accessdata.fda.gov |
| March 12, 2018 | 79751 | Class II | Terminated | Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adul | The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling | accessdata.fda.gov |
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- All makers of Screw, Fixation, Bone
- All makers of Rod, Fixation, Intramedullary And Accessories
Updated July 29, 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.