BEUDAMED
    FDA Recall Terminated

    OmniFit Eon 127 degree and 132 degree Surgical Protocol; Stryker. Surgical protocols instruct surgeons on proper surgical technique.

    Recall: Z-0506-2010 · Initiated August 31, 2009

    Recall

    Recall Number
    Z-0506-2010
    Event Number
    53386
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    August 31, 2009
    Posted
    January 11, 2010
    Terminated
    July 17, 2013
    Address
    325 Corporate Drive, Mahwah, NJ, 07430

    Description

    OmniFit Eon 127 degree and 132 degree Surgical Protocol; Stryker. Surgical protocols instruct surgeons on proper surgical technique.

    Reason

    Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.

    Action

    "Urgent Product Correction - Surgical Protocol" letters and Product Accountability Forms were sent to consignees via Fed Ex on August 31, 2009 and September 1, 2009 with return receipt. Notification letters described the issue, protocols affected, potential hazard and harm and risk mitigation. Direct questions about the recall by calling 1-201-972-2100 or Customer Service 1 -866-OR-ASSIST (1 -866-672-7747).

    Distribution

    Worldwide Distribution.

    Quantity

    978