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

FDA device recall Z-0479-2026 · posted 2025-11-07 · Open, Classified

Recall details

Recalling firm

Miach Orthopaedics

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

QNI

Quantity affected

167 units

Distribution

US Nationwide distribution.

Date initiated

2023-02-02

Date posted

2025-11-07

Location

Westborough, MA

Related 510(k) clearances