Wright Medical Technology recalls
Wright Medical Technology appears in 79 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-07.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 79 |
|---|---|
| Published | 2012-11-07 to 2026-10-07 |
| By agency | FDA Device (79) |
| By classification | Class II (79) |
| By status | terminated (64), ongoing (15) |
| Distribution named in notices | AZ, CA, CO, FL, GA, IA, ID, MA, MO, NC, NE, NY, OH, PA, TX, US, VA, WV |
Recalls
- CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
FDA Device · Class II · 2026-10-07 · Wright Medical Technology
Reason: Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the p… - stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
FDA Device · Class II · 2024-04-10 · Wright Medical Technology
Reason: Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument a… - Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile
FDA Device · Class II · 2023-07-12 · Wright Medical Technology
Reason: The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes. - stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
FDA Device · Class II · 2023-05-03 · Wright Medical Technology
Reason: Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. - stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
FDA Device · Class II · 2023-05-03 · Wright Medical Technology
Reason: Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. - ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
FDA Device · Class II · 2023-03-08 · Wright Medical Technology
Reason: Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S04… - ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
FDA Device · Class II · 2023-03-08 · Wright Medical Technology
Reason: Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S04… - Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
FDA Device · Class II · 2022-11-02 · Wright Medical Technology
Reason: The tibial tray lock detail is oversized (larger than specification). - Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
FDA Device · Class II · 2022-11-02 · Wright Medical Technology
Reason: The tibial tray lock detail is oversized (larger than specification). - stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set co…
FDA Device · Class II · 2022-10-12 · Wright Medical Technology
Reason: The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm… - stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set c…
FDA Device · Class II · 2022-10-12 · Wright Medical Technology
Reason: The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm… - Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile
FDA Device · Class II · 2022-08-31 · Wright Medical Technology
Reason: An incorrect sizing label was applied to the carton packaging. - Wright EVOLVE TRIAD Plate Cutter, REF 49510120
FDA Device · Class II · 2022-07-20 · Wright Medical Technology
Reason: The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use - Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle Syst…
FDA Device · Class II · 2022-07-06 · Wright Medical Technology
Reason: The instrument is incorrectly color coded. - EasyFuse Dynamic Compression System Instrument Pack
FDA Device · Class II · 2022-04-06 · Wright Medical Technology
Reason: The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking. - Wright Medical Technology, Inc
FDA Device · Class II · 2022-03-23 · Wright Medical Technology
Reason: An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw. - The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium
FDA Device · Class II · 2022-03-09 · Wright Medical Technology
Reason: Product was labelled with the incorrect manufacturing and distribution dates. - Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430
FDA Device · Class II · 2021-12-29 · Wright Medical Technology
Reason: The incorrect product is contained in the packaging. - Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm
FDA Device · Class II · 2021-12-29 · Wright Medical Technology
Reason: The incorrect product is contained in the packaging. - Wright Medical Technology Inc
FDA Device · Class II · 2021-12-29 · Wright Medical Technology
Reason: Incorrect product is contained in the packaging. - INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
FDA Device · Class II · 2021-12-08 · Wright Medical Technology
Reason: The package contents and package labeling do not match. - INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
FDA Device · Class II · 2021-12-08 · Wright Medical Technology
Reason: The package contents and package labeling do not match. - EVOLVE STEM 8.5MM Model # 496S085
FDA Device · Class II · 2020-09-30 · Wright Medical Technology
Reason: Lack of sterility assurance - Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of bo…
FDA Device · Class II · 2020-08-19 · Wright Medical Technology
Reason: Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. - Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical hardware removal kit is designed to facilitate remova…
FDA Device · Class II · 2020-08-19 · Wright Medical Technology
Reason: Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. - WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by r…
FDA Device · Class II · 2020-05-13 · Wright Medical Technology
Reason: One lot of INBONE Tibial Trays is missing the plasma coating. - WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
FDA Device · Class II · 2020-02-12 · Wright Medical Technology
Reason: Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product. - WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
FDA Device · Class II · 2020-02-12 · Wright Medical Technology
Reason: Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product. - SWANSON TRAPEZIUM IMPLANT, Part Number 4520002
FDA Device · Class II · 2019-12-04 · Wright Medical Technology
Reason: The firm discovered a lack of adequate documentation confirming sterility on certain products. - VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045
FDA Device · Class II · 2019-12-04 · Wright Medical Technology
Reason: The firm discovered a lack of adequate documentation confirming sterility on certain products. - SWANSON FINGER JOINT #1, Part Number 4700001
FDA Device · Class II · 2019-12-04 · Wright Medical Technology
Reason: The firm discovered a lack of adequate documentation confirming sterility on certain products. - Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S
FDA Device · Class II · 2019-12-04 · Wright Medical Technology
Reason: The firm discovered a lack of adequate documentation confirming sterility on certain products. - CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001
FDA Device · Class II · 2019-12-04 · Wright Medical Technology
Reason: The firm discovered a lack of adequate documentation confirming sterility on certain products. - INBONE STEM, TIBIAL, TOP, Part Number 200011901
FDA Device · Class II · 2019-12-04 · Wright Medical Technology
Reason: The firm discovered a lack of adequate documentation confirming sterility on certain products. - ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538
FDA Device · Class II · 2019-12-04 · Wright Medical Technology
Reason: The firm discovered a lack of adequate documentation confirming sterility on certain products. - EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010
FDA Device · Class II · 2019-12-04 · Wright Medical Technology
Reason: The firm discovered a lack of adequate documentation confirming sterility on certain products. - Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514
FDA Device · Class II · 2019-12-04 · Wright Medical Technology
Reason: The firm discovered a lack of adequate documentation confirming sterility on certain products. - SWANSON FINGER JOINT #2, Part Number 4700002
FDA Device · Class II · 2019-12-04 · Wright Medical Technology
Reason: The firm discovered a lack of adequate documentation confirming sterility on certain products. - PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
FDA Device · Class II · 2019-12-04 · Wright Medical Technology
Reason: The firm discovered a lack of adequate documentation confirming sterility on certain products. - SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104
FDA Device · Class II · 2019-12-04 · Wright Medical Technology
Reason: The firm discovered a lack of adequate documentation confirming sterility on certain products. - WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R
FDA Device · Class II · 2018-04-25 · Wright Medical Technology
Reason: Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw. - WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020
FDA Device · Class II · 2018-04-25 · Wright Medical Technology
Reason: Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw. - CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008
FDA Device · Class II · 2015-09-09 · Wright Medical Technology
Reason: These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction. - CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008
FDA Device · Class II · 2015-09-09 · Wright Medical Technology
Reason: These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction. - PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1 EACH, RX ONLY
FDA Device · Class II · 2015-05-27 · Wright Medical Technology
Reason: The term DORSAL was laser etched on the incorrect side on some of the angled handles. - PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONTENTS 1 EACH, RX ONLY
FDA Device · Class II · 2015-05-27 · Wright Medical Technology
Reason: The term DORSAL was laser etched on the incorrect side on some of the angled handles. - PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CONTENTS 1 EACH, RX ONLY
FDA Device · Class II · 2015-05-27 · Wright Medical Technology
Reason: The term DORSAL was laser etched on the incorrect side on some of the angled handles. - PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY
FDA Device · Class II · 2015-05-27 · Wright Medical Technology
Reason: The term DORSAL was laser etched on the incorrect side on some of the angled handles. - CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology
Reason: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction - CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology
Reason: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction