BEUDAMED
    FDA Recall 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 · Initiated November 20, 2013

    Recall

    Recall Number
    Z-0964-2014
    Event Number
    67234
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 20, 2013
    Posted
    February 10, 2014
    Terminated
    October 13, 2016
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    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.

    Action

    Stryker Orthopaedics sent notification letters and acknowledgement forms via Fed Ex as follows: Branches-11/20/2013 Hospital Risk Manager - 11/21/2013

    Distribution

    IL MA, MN, ND, OR, & PA

    Quantity

    211 units