FDAClass IINovember 19, 2025

BEAR Implant recall

BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;

Why was BEAR Implant recalled?

The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model/Catalog: 1000; UDI-DI: 00860002987804; Lot number: 7008409;

Product
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Recalling firm
Miach Orthopaedics
Quantity
167 units
Distribution
US Nationwide distribution.
Recall date
November 19, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls