Recall Z-1220-2026 · QNI Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
Miach Orthopaedics
BEAR Implant. Model Number: 1000.
| Date | Jan 29, 2026 (initiated Dec 31, 2025) |
| Status | Open, Classified |
| Reason | Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect. |
| Root cause | Process control |
| Action | Notification to Sales Representatives and consignees began on about 12/31/2025 via email and letter titled URGENT MEDICAL DEVICE RECALL NOTIFICATION. Consignees were instructed to identify and quarantine all unused inventory of the affected lot, discontinue distribution of the affected lot, return all unused affected product, and complete and return the provided Recall Acknowledgement Form. Additionally, consignees were requested to notify customers if the affected lot was further distributed. |
| Quantity | 284 units |
| Distribution | US Nationwide distribution in the states of AK, CA, CO, CT, FL, GA, IL, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, TX, VA, WA, WI. |
| 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 |