FDA Medical Device Recalls (openFDA)
Miach Orthopaedics: BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
- Recall number
- Z-0479-2026
- Recalling firm
- Miach Orthopaedics
- Product
- BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
- Status
- Open, Classified
- Initiated
- 2023-02-02
- Posted
- 2025-11-07
- Terminated
- not on file
- Reason
- The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
- Root 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
- 167 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Model/Catalog: 1000; UDI-DI: 00860002987804; Lot number: 7008409;
- 510(k) numbers
- ["K243578"]
- PMA numbers
- not on file
- Product code
- QNI
- Firm FEI
- 3020652309
- Firm city
- Westborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28