BEUDAMED
    FDA Enforcement Class II Ongoing

    MICS3 Angled Sagittal Saw Attachment; Part Number: 210490

    Recall: Z-1572-2026 · Reported March 25, 2026

    Enforcement

    Recall Number
    Z-1572-2026
    Event ID
    98411
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2026
    Initiation Date
    February 2, 2026
    Classification Date
    March 18, 2026
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    MICS3 Angled Sagittal Saw Attachment; Part Number: 210490

    Reason

    A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.

    Code Info

    Part Number: 210490; UDI: (01)07613327523874(10)TU6563205RP; Lot numbers: ALL;

    Distribution

    Domestic: Nationwide Distribution; International: Australia, Germany, Belgium, France, Spain UK, New Zealand;

    Quantity

    1098 units