FDA DevicesClass II
BEAR Implant. Model Number: 1000.
Published: February 4, 2026Recall ID: Z-1220-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
BEAR Implant. Model Number: 1000.
Additional Source Details
| Field | Value |
|---|---|
| City | Westborough |
| State | MA |
| Event id | 98280 |
| Address 1 | 69 Milk St Ste 100 |
| Address 2 | N/A |
| Code info | Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026. |
| Postal code | 01581-1224 |
| Report date | 20260204 |
| Product type | Devices |
| Product quantity | 284 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251231 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260129 |
Overview
- Recalling FirmMiach Orthopaedics
- StatusOngoing
- Risk LevelClass II
- DistributionUS 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.