FDA Medical devices recall ·
BEAR Implant (Bridge-Enhanced ACL Restoration) recall
- Recall number
- Z-0479-2026
- Date
- (initiated February 2, 2023)
- Company / brand
- Miach Orthopaedics
69 Milk St Ste 100, Westborough, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 167 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Why was it recalled?
The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/Catalog: 1000; UDI-DI: 00860002987804; Lot number: 7008409;
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0479-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.