BEUDAMED
    FDA Recall Terminated

    Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169540521); and Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169641006) (Japan). The percutaneous pin adapter is a component of the StealthAir Frame Assembly.

    Recall: Z-0707-2020 · Initiated December 6, 2018

    Recall

    Recall Number
    Z-0707-2020
    Event Number
    84045
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    1000517638
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 6, 2018
    Terminated
    December 17, 2020
    Address
    826 Coal Creek Cir, Louisville, CO, 80027-9710

    Description

    Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169540521); and Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169641006) (Japan). The percutaneous pin adapter is a component of the StealthAir Frame Assembly.

    Reason

    Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and not return to its original position, even when connections are tight and secure.

    Action

    The recalling firm issued a Dear Healthcare Professional letter dated 12/6/2018 via FedEx explaining the issue and requesting the consignee examine their inventory and quarantine the percutaneous pin adapter for return to the firm. Only the percutaneous pin adapter was to be returned and not the remaining items in the assembly.

    Distribution

    Distribution was nationwide. There was government/military/foreign distribution.

    Quantity

    1,297 percutaneous pin adapters