BEUDAMED
    FDA Recall Terminated

    MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.

    Recall: Z-0922-2012 · Initiated December 16, 2011

    Recall

    Recall Number
    Z-0922-2012
    Event Number
    60964
    Firm
    Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
    FEI Number
    1000131961
    Product Code
    FTM
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 16, 2011
    Posted
    January 27, 2012
    Terminated
    June 21, 2012
    Address
    15 Dart Rd, Newnan, GA, 30265-1017

    Description

    MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.

    Reason

    The template that is packaged with this implant was not packaged according to specification. The template was packaged in a single pouch instead of a double pouch.

    Action

    "Urgent Product Recall" Notification letters and Product Accountability Forms have been sent on January 13, 2012 domestically via FedEx and Internationally via DHL. Customers were informed of the product problem and provided risk mitigation information. Return of the Product Accountability/Acknowledgement form was requested. Questions were directed to 770-254-4423.

    Distribution

    Worldwide Distribution - USA, the state of Michigan, and the countries of Australia and Canada.

    Quantity

    10 units