BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile

    Recall: Z-0964-2014 · Reported February 19, 2014

    Enforcement

    Recall Number
    Z-0964-2014
    Event ID
    67234
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2014
    Initiation Date
    November 20, 2013
    Classification Date
    February 10, 2014
    Termination Date
    October 13, 2016
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2002, United States

    Description

    Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile

    Reason

    Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.

    Code Info

    Catalog no. 2124-1400 All lots

    Distribution

    IL MA, MN, ND, OR, & PA

    Quantity

    211 units