BEUDAMED
    FDA Recall Terminated

    CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L. Orthopedic use.

    Recall: Z-1488-2015 · Initiated March 6, 2015

    Recall

    Recall Number
    Z-1488-2015
    Event Number
    70859
    Firm
    Wright Medical Technology, Inc.
    FEI Number
    3010667733
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 6, 2015
    Posted
    April 22, 2015
    Terminated
    August 5, 2018
    Address
    1023 Cherry Rd, Memphis, TN, 38117-5423

    Description

    CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L. Orthopedic use.

    Reason

    The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction

    Action

    Firm has initiated the recall on 03/06/2015 through written communication via Fed Ex P1 delivery to all Wright Medical Technologies distributors (hubs). Follow-up to non-responding consignees will commence 30 days after initiation. Effectiveness checks will be performed through the confirmation of returned product via a validated ERP system, a returned/signed verification form, and in the case of non-responders, a phone call, e-mail or follow up letter, depending on the region and availability of consignee.

    Distribution

    Nationwide Distribution.

    Quantity

    148 units