FDA-Device2025-11-19Class IIPACKAGING DEFECT
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Hazard
The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
167 units
Manufactured in
69 Milk St Ste 100, Westborough, MA, United States
Products
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0479-2026Want us to check the next one for you?
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