BEUDAMED
    FDA Enforcement Class II Completed

    SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.

    Recall: Z-1572-2022 · Reported August 31, 2022

    Enforcement

    Recall Number
    Z-1572-2022
    Event ID
    90542
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    SAFE ORTHOPAEDICS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2022
    Initiation Date
    June 3, 2022
    Classification Date
    August 24, 2022
    Address
    700 W Irving Park Rd, Chicago, IL, 60613-1170, United States

    Description

    SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.

    Reason

    The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.

    Code Info

    KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and KITM740: Lot number BL0A01; UDI 03760219910091.

    Distribution

    Distribution was made to MD. There was no government/military distribution.

    Quantity

    8 devices