Stryker Gmbh
FDA adverse event reports naming Stryker Gmbh as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: STRYKER GMBH.
- Total reports
- 15,151
- Deaths
- 34
- Injuries
- 10,990
- Malfunctions
- 4,127
Reports per year
Source: FDA adverse event reports by year received, 2013–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Plate, Fixation, BoneHRS3,014
- Rod, Fixation, Intramedullary And AccessoriesHSB2,581
- Screw, Fixation, BoneHWC2,386
- Orthopedic Manual Surgical InstrumentLXH1,368
- Prosthesis, Ankle, Uncemented, Non-ConstrainedNTG1,330
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT865
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS762
- Pin, Fixation, ThreadedJDW731
- Pin, Fixation, SmoothHTY408
- Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-ConstrainedJWJ255
Recent recalls
- 2026-07-29Open, ClassifiedDevice Design
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.
- 2026-07-29Open, ClassifiedDevice Design
Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- 2026-07-29Open, ClassifiedDevice Design
Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- 2026-07-29Open, ClassifiedDevice Design
Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- 2026-07-29Open, ClassifiedDevice Design
Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- 2026-07-29Open, ClassifiedDevice Design
Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- 2026-07-29Open, ClassifiedDevice Design
Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- 2025-06-10Open, ClassifiedUnder Investigation by firm
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.
- 2025-06-10Open, ClassifiedUnder Investigation by firm
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
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.
- 2025-06-06Open, ClassifiedProcess design
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.
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