The BEAR Implant (Bridge-Enhanced ACL Restoration), Model/Catalog 1000 (UDI‑DI 00860002987804), Lot 7008409 — 167 units distributed nationwide in the United States — is being recalled by Miach Orthopaedics. The field action was initiated in February 2023 and was limited to the affected lot from sales force trunk stock only.
What's being recalled
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Recalling firm: Miach Orthopaedics, Westborough, MA, United States.
How to identify it
Model/Catalog: 1000; UDI-DI: 00860002987804; Lot number: 7008409;
The hazard
The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)