FDAJune 3, 2016device
Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
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.
- FDATRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.2026-05-19
- 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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