BEAR Implant. Model Number: 1000.
FDA Recall #Z-1220-2026 — Class II — December 31, 2025
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.
Recalling Firm
Miach Orthopaedics — Westborough, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
Code Information
Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated