Miach Orthopaedics recalls BEAR Implant (Bridge-Enhanced ACL Restoration)

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

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-0479-2026
• FDA 510(k) clearance · K243578The device's official FDA premarket clearance record
• FDA device classification · QNIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3044The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Miach OrthopaedicsSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.