FDAHealthFebruary 2, 2023
Miach Orthopaedics — BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
⚠️ The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 2, 2023
US Nationwide distribution.
What's affected?
- Product
- BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
- Brand
- Miach Orthopaedics
- Lot code
- 7008409
Additional details
Model/Catalog: 1000; UDI-DI: 00860002987804; Lot number: 7008409;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 167 units.
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