Miach Orthopaedics: Device Recall
Recall #Z-1220-2026 · 12/31/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1220-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Miach Orthopaedics
- Status
- Ongoing
- Date Initiated
- 12/31/2025
- Location
- Westborough, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- 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.
Product Description
BEAR Implant. Model Number: 1000.
Distribution Pattern
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.