FDA Enforcement
Class II
Ongoing
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Recall: Z-0479-2026
·
Reported November 19, 2025
Enforcement
- Recall Number
- Z-0479-2026
- Event ID
- 97742
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Miach Orthopaedics
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 19, 2025
- Initiation Date
- February 2, 2023
- Classification Date
- November 7, 2025
- Address
- 69 Milk St Ste 100, Westborough, MA, 01581-1224, United States
Description
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.
Code Info
Model/Catalog: 1000; UDI-DI: 00860002987804; Lot number: 7008409;
Distribution
US Nationwide distribution.
Quantity
167 units