Miach Orthopaedics: BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Miach Orthopaedics
- Product
- BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2023-02-02
- Code info
- Model/Catalog: 1000; UDI-DI: 00860002987804; Lot number: 7008409;
- Product quantity
- 167 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Westborough
- State
- MA
- Country
- United States
- Event id
- 97742
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