Z-0479-2026 Class II Ongoing
FDA device recall Z-0479-2026 was initiated by Miach Orthopaedics on February 2, 2023 and is designated Class II. Reason for recall: The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only. The recall status is ongoing. Affected quantity: 167 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 19, 2025
- Initiation Date
- February 2, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 167 units
Product Description
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Reason for Recall
The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
Distribution Pattern
US Nationwide distribution.
Code Information
Model/Catalog: 1000; UDI-DI: 00860002987804; Lot number: 7008409;