BEUDAMED
    FDA Enforcement Class II Terminated

    Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty.

    Recall: Z-0783-2014 · Reported January 29, 2014

    Enforcement

    Recall Number
    Z-0783-2014
    Event ID
    66846
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 29, 2014
    Initiation Date
    December 19, 2013
    Classification Date
    January 17, 2014
    Termination Date
    February 24, 2015
    Address
    345 E Main St, Warsaw, IN, 46580-2746, United States

    Description

    Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty.

    Reason

    After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.

    Code Info

    Part numbers 00-5850-012-95

    Distribution

    Worldwide Distribution. USA nationwide and Germany, with further distribution into EU countries.

    Quantity

    5305 distribution events