Z-1220-2026 Class II Ongoing
FDA device recall Z-1220-2026 was initiated by Miach Orthopaedics on December 31, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 284 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 4, 2026
- Initiation Date
- December 31, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 284 units
Product Description
BEAR Implant. Model Number: 1000.
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.
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.
Code Information
Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.