BEUDAMED
    FDA Enforcement Class II 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 · Reported August 22, 2012

    Enforcement

    Recall Number
    Z-2187-2012
    Event ID
    62499
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2012
    Initiation Date
    July 13, 2012
    Classification Date
    August 10, 2012
    Termination Date
    September 24, 2013
    Address
    345 E Main St, Warsaw, IN, 46580-2746, United States

    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.

    Code Info

    Part number 02.03155.026, lot 2649941

    Distribution

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

    Quantity

    24 to US Distributor with 7 further distributed