BEUDAMED
    FDA Recall Completed

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

    Recall: Z-1572-2022 · Initiated June 3, 2022

    Recall

    Recall Number
    Z-1572-2022
    Event Number
    90542
    Firm
    SAFE ORTHOPAEDICS LLC
    FEI Number
    3018359693
    Product Code
    NKB
    Status
    Completed
    Root Cause
    Labeling Change Control
    Initiated
    June 3, 2022
    Address
    700 W Irving Park Rd, Chicago, IL, 60613-1170

    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.

    Action

    The recall letter was issued on 6/3/2022 via email to the firm's one U.S. customer. The email included a dealer recall letter, dealer response form, and a template letter for notification of any hospitals who received the product from the dealer. The letter requested the products be quarantined and the dealer should contact the hospitals who received the product to notify them of the incorrect patient labels.

    Distribution

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

    Quantity

    8 devices