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: 15,073
Deaths: 34
Injuries: 10,957
Malfunctions: 4,082

Reports per year

Source: FDA adverse event reports by year received, 2013–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

Recent recalls

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.
2025-04-17Open, ClassifiedDevice Design
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.
2025-04-17Open, ClassifiedDevice Design
Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
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.
2024-06-27Open, ClassifiedProcess change control
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.
2023-03-01Open, ClassifiedProcess change control
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.
2020-06-16TerminatedProcess control
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
2020-06-16TerminatedProcess control
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - 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
2020-06-16TerminatedProcess control
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - 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

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