Device product
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Z-0479-2026
Product summary
- Event
- Event 97742
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 167 units
- Official record key
device-enforcement:Z-0479-2026
Official wording
Reason: The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
Code information: Model/Catalog: 1000; UDI-DI: 00860002987804; Lot number: 7008409;
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.