BEAR Implant. Model Number: 1000.
FDA device recall Z-1220-2026 · posted 2026-01-29 · Open, Classified
Recall details
- Recalling firm
- Miach Orthopaedics
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- QNI
- Quantity affected
- 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.
- Date initiated
- 2025-12-31
- Date posted
- 2026-01-29
- Location
- Westborough, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BEAR® (Bridge-Enhanced ACL Restoration) Implant (K243578) | Miach Orthopaedics, Inc. | 2025-03-06 |