BEAR Implant — Class II medical device recall Z-0479-2026
Ongoing recall by Miach Orthopaedics, reported 2025-11-19, distributed nationwide. The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk
| Recall number | Z-0479-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Miach Orthopaedics, Westborough, MA, United States |
| Recall initiated | 2023-02-02 |
| Classified | 2025-11-07 |
| Reported by FDA | 2025-11-19 |
| Distributed | Nationwide (US) |
| Quantity | 167 units |
| UPC / GTIN / UDI-DI | 00860002987804 |
| Lot numbers | 7008409 |
| Model numbers | 1000 |
Product
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Reason for recall
The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
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-0479-2026. 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.