BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.

    Recall: Z-0582-2014 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0582-2014
    Event ID
    66909
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2014
    Initiation Date
    September 30, 2013
    Classification Date
    December 26, 2013
    Termination Date
    October 19, 2016
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2002, United States

    Description

    Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.

    Reason

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

    Code Info

    Catalog number 12350-013 all lot codes

    Distribution

    USA Nationwide Distribution

    Quantity

    1,690 units