Miach Orthopaedics recalls BEAR Implant
- Recalling company
- Miach Orthopaedics
- Product
- BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
- Reason
- The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Feb 2, 2023
- Reported
- Nov 19, 2025
- Distribution
- US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 167 units
- Lot / codes
- Model/Catalog: 1000; UDI-DI: 00860002987804; Lot number: 7008409;
- Company location
- Westborough, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0479-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0479-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.