Reported May 4, 2022 · Ongoing
Smart Toe II Intramedullary Arthrodesis Implant
Stryker GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker GmbH · Bohnackerweg 1 · Selzach · N/A
Is this the product you have?
- Smart Toe II Intramedullary Arthrodesis Implant
- Lot codes and dates
11 of 11 products
Products covered by this recall Model / number Barcodes Product as published ST0XS-13— — 07613252263470UDI: 07613252263470 ST0-19PLot Code (Expiration Date): H52262 (08/31/2026) — 07613252263340UDI: 07613252263340 ST0A-16PLot Code (Expiration Date): H54191 (08/31/2026) — 07613252263418UDI: 07613252263418 ST0XS-11Lot Code (Expiration Date): H54193 (09/30/2026) — 07613252263456UDI: 07613252263456 ST0-22PLot Code (Expiration Date): H55690 (09/30/2026) — 07613252263388UDI: 07613252263388 — Lot Code (Expiration Date): H56502 (09/30/2026) - Amount recalled
- 246 implants
Where it was sold
- Nationwide
Why it was recalled
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".
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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