FDANovember 9, 2016device
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error.
What to do
FDA enforcement status: Terminated
Brands named
stryker howmedica osteonicsstrykerstryker howmedica
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDATRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.2026-05-19
- FDANeptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System2026-05-06
- FDADaig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic Tip Steerable, Product Number 6DYNTP001;2026-04-10
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