Recall Z-0479-2026 · QNI Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
Miach Orthopaedics
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
| Date | Nov 7, 2025 (initiated Feb 2, 2023) |
| Status | Open, Classified |
| 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 de |
| Quantity | 167 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243578 | BEAR® (Bridge-Enhanced ACL Restoration) Implant Miach Orthopaedics, Inc., Mar 6, 2025 |