BEUDAMED
    FDA Recall Terminated

    Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.

    Recall: Z-0583-2014 · Initiated September 30, 2013

    Recall

    Recall Number
    Z-0583-2014
    Event Number
    66909
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    HWA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 30, 2013
    Posted
    December 27, 2013
    Terminated
    October 19, 2016
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.

    Reason

    Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.

    Action

    Stryker sent an Urgent Medical Device Correction letter dated October 1, 2013 to all affected customers via Fed Ex. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and fax the attached Product Correction Acknowledgement form to 855-251-3635.

    Distribution

    USA Nationwide Distribution

    Quantity

    1,024 units