FDA recall record · openFDA

Stryker GmbH

7 FDA recalls on record (2023–2025) — 7 device. 7 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained 2

The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use i 2

The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly. 1

Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail. 1

Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread 1

Recalls

Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S. Class II 2025-05-22 Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S. Class II 2025-05-28 Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S. Class II 2025-05-22 Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S; Class II 2025-03-28 Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S; Class II 2025-03-28 Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System. Class II 2024-05-09 stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bon Class II 2023-02-07

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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