FDAMarch 28, 2022device
Smart Toe II Intramedullary Arthrodesis Implant
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity".
What to do
FDA enforcement status: Ongoing
Brands named
stryker
UPCs
0761325226347007613252263340076132522634180761325226345607613252263388
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- 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
- FDABARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic Tip Steerable, Product Number 6DYNTP001;2026-04-10
- FDABARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDADaig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
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