Smart Toe II Intramedullary Arthrodesis Implant — Class II medical device recall Z-1011-2022
Ongoing recall by Stryker GmbH, reported 2022-05-04, distributed nationwide. The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the stat
| Recall number | Z-1011-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker GmbH, Selzach, Switzerland |
| Recall initiated | 2022-03-28 |
| Classified | 2022-04-27 |
| Reported by FDA | 2022-05-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CL, CN, DE, ES, FR, GB, NL, NZ, SE |
| Quantity | 246 implants |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07613252263340, 07613252263388, 07613252263418, 07613252263456, 07613252263470 |
| Lot numbers | H52262, H54191, H54193, H55690, H56502 |
| Model numbers | ST0-19P, ST0-22P, ST0A-16P, ST0XS-11, ST0XS-13 |
Product
Smart Toe II Intramedullary Arthrodesis Implant
Reason for recall
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".
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1011-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.