Z-1220-2026 Class II Ongoing

Recalled by Miach Orthopaedics — Westborough, MA

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.