Wright Medical Technology Inc
FDA adverse event reports naming Wright Medical Technology Inc as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: WRIGHT MEDICAL TECHNOLOGY INC.
- Total reports
- 4,671
- Deaths
- 1
- Injuries
- 4,396
- Malfunctions
- 274
Reports per year
Source: FDA adverse event reports by year received, 1996–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerHSN3,838
- Screw, Fixation, BoneHWC209
- Plate, Fixation, BoneHRS196
- Staple, Fixation, BoneJDR112
- Prosthesis, Elbow, Hemi-, Radial, PolymerKWI94
- Prosthesis, Metatarsophalangeal Joint Cartilage Replacement ImplantPNW26
- Guide, Surgical, InstrumentFZX24
- Orthopedic Manual Surgical InstrumentLXH23
- Filler, Bone Void, Calcium CompoundMQV22
- Rod, Fixation, Intramedullary And AccessoriesHSB16
Recent recalls
- 2024-04-04Open, ClassifiedProcess change control
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
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 assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.
- 2023-07-07Open, ClassifiedProcess control
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
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.
- 2023-04-26Open, ClassifiedEmployee error
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
- 2023-04-26Open, ClassifiedEmployee error
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
- 2023-02-24Open, ClassifiedEmployee error
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
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 402S0425 incorrectly contained 40241425, and vice versa.
- 2023-02-24Open, ClassifiedEmployee error
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
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 402S0425 incorrectly contained 40241425, and vice versa.
- 2022-10-27Open, ClassifiedDevice Design
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
The tibial tray lock detail is oversized (larger than specification).
- 2022-10-27Open, ClassifiedDevice Design
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
The tibial tray lock detail is oversized (larger than specification).
- 2022-10-04Open, ClassifiedUnder Investigation by firm
stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
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 +2 stem.
- 2022-10-04Open, ClassifiedUnder Investigation by firm
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 configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
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 +2 stem.
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