BEUDAMED
    FDA Recall Terminated

    Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.

    Recall: Z-2428-2015 · Initiated June 24, 2015

    Recall

    Recall Number
    Z-2428-2015
    Event Number
    71676
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JDB
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    June 24, 2015
    Posted
    August 20, 2015
    Terminated
    April 29, 2016
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006

    Description

    Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.

    Reason

    Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.

    Action

    Branches/Agencies were notified by Stryker of this action by e-mails on June 24, 2015 and an Urgent Medical Device Removal Letter/Acknowledgement Response Form dated June 25, 2015 was sent to the attention of the Risk Manager.

    Distribution

    Worldwide Distribution.

    Quantity

    16992 total