BEUDAMED
    FDA Recall Terminated

    The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage.

    Recall: Z-2187-2012 · Initiated July 13, 2012

    Recall

    Recall Number
    Z-2187-2012
    Event Number
    62499
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 13, 2012
    Posted
    August 10, 2012
    Terminated
    September 24, 2013
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage.

    Reason

    Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained incorrect 32 mm screws.

    Action

    The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL" letter dated July 13, 2012, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to locate the implicated lot in their inventory and user accounts; return all packaged units of this lot; and provide Zimmer with the name, complete mailing address, and phone number of each user facility and surgeon that have used the product via E-mail to [email protected]. Zimmer will send a follow-up Urgent Recall notification to these sub-accounts with instructions to verify the screw length of any screws already in the implant rack inventory prior to use in surgery. All implicated product is to be returned. The customers were also instructed to complete and return the Inventory Return Certification form to Zimmer via fax at +1-574-372-4265. If you have any questions about this correction and/or product removal, contact Zimmer at +1-877-946-2761.

    Distribution

    Nationwide distribution: USA including states of: AZ, IL, IN, ME and NJ.

    Quantity

    24 to US Distributor with 7 further distributed