BEUDAMED
    FDA Recall Terminated

    Stryker Custom Cranial Implant Kit, extra large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00104. Custom cranial implant designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.

    Recall: Z-0512-2009 · Initiated October 24, 2008

    Recall

    Recall Number
    Z-0512-2009
    Event Number
    50172
    Firm
    Stryker Craniomaxillofacial Division
    FEI Number
    3005101424
    Product Code
    KKY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 24, 2008
    Posted
    December 18, 2008
    Terminated
    December 31, 2009
    Address
    750 Trade Centre Way, Ste 200, Portage

    Description

    Stryker Custom Cranial Implant Kit, extra large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00104. Custom cranial implant designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.

    Reason

    Lack of assurance of sterility.

    Action

    The firm's sales representatives and consignee risk managers, as well as implanting surgeons, were notified individually of the problem via recall letter dated 10/24/08, advised of the risk for serious infections, and instructed to follow-up with patients for infections for at least six months after surgery. The recall letter also included details for identifying and returning any remaining implant kits. Direct questions to Stryker's RA/QA Representative 269-324-5346 ext. 4258. The firm issued a press release concerning this recall on 12/23/08.

    Distribution

    Nationwide Distribution.

    Quantity

    322 of all products.