Class 2 Device Recall BEAR

• Date Initiated by Firm: February 02, 2023
• Date Posted: November 07, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0479-2026
• Recall Event ID: 97742
• 510(K)Number: K243578
• Product Classification: Resorbable implant for anterior cruciate ligament (ACL) repair - Product Code QNI
• Product: BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000
• Code Information: Model/Catalog: 1000; UDI-DI: 00860002987804; Lot number: 7008409
• Recalling Firm/ Manufacturer: Miach Orthopaedics; 69 Milk St Ste 100; Westborough MA 01581-1224
• For Additional Information Contact: Gregory DeVenne; 800-590-6995
• Manufacturer Reason for Recall: The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
• FDA Determined Cause: Under Investigation by firm
• Action: On January 30, 2023 RE: BEAR Implant Hydration memo emails were sent to sales staff. If you observe an implant that hydrates too quickly (e.g., less than 30 seconds) and appears that it may not remain intact upon insertion into the knee, do not attempt to implant the device. We would recommend you always have a backup device available to address such circumstances. We plan to revise the Tips and Pearls document, ML-1027, to provide further instructions/details on how to properly hydrate the BEAR device. In the meantime, one way to avoid shortened hydration time is to consider hydrating the dense side of the implant first and continue toward the porous side . To date, all reports of this observation have involved Lot # 7008409. As a precaution and to ensure customer satisfaction, we are asking that you return all devices from this lot that are currently in your trunk stock (in your possession). Chris Brown will work with you to coordinate returns as well as replacing these trunk stock devices. Please contact me (mohara@miachortho.com) or Arjun (aishwar@miachortho.com) if you have questions.
• Quantity in Commerce: 167 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = QNI