BEUDAMED
    FDA Enforcement Class II Ongoing

    BEAR Implant. Model Number: 1000.

    Recall: Z-1220-2026 · Reported February 4, 2026

    Enforcement

    Recall Number
    Z-1220-2026
    Event ID
    98280
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Miach Orthopaedics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 4, 2026
    Initiation Date
    December 31, 2025
    Classification Date
    January 29, 2026
    Address
    69 Milk St Ste 100, N/A, Westborough, MA, 01581-1224, United States

    Description

    BEAR Implant. Model Number: 1000.

    Reason

    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.

    Code Info

    Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.

    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.

    Quantity

    284 units