BEAR Implant — Class II medical device recall Z-1220-2026
Ongoing recall by Miach Orthopaedics, reported 2026-02-04, distributed nationwide. Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an i
| Recall number | Z-1220-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Miach Orthopaedics, Westborough, MA, United States |
| Recall initiated | 2025-12-31 |
| Classified | 2026-01-29 |
| Reported by FDA | 2026-02-04 |
| Distributed | Nationwide (US) |
| Quantity | 284 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00860002987804 |
| Lot numbers | 7011098 |
| Model numbers | 1000 |
| Expiration dates | 2026-02-28 |
Product
BEAR Implant. Model Number: 1000.
Reason for recall
Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
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-1220-2026. 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.