FDA-Device2025-11-19Class II
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Miach Orthopaedics
Hazard
The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
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-0479-2026Don't want to check this manually?
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