13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX — Class II medical device recall Z-1234-2024
Ongoing recall by Synthes (USA) Products LLC, reported 2024-03-13, distributed nationwide. Products not sterilized, sterility cannot be confirmed
| Recall number | Z-1234-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2024-01-24 |
| Classified | 2024-03-01 |
| Reported by FDA | 2024-03-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CA, CZ, DE, ES, FI, FR, GB, IE, KR, KW, MX, NL, SK, TW, ZA |
| Quantity | 5 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10886982087331 |
| Lot numbers | 41P2222 |
| Model numbers | 04.008.378S |
Product
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
Reason for recall
Products not sterilized, sterility cannot be confirmed
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-1234-2024. 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.