BEUDAMED
    FDA Recall Terminated

    Products are surgical drills packaged separately or included in a surgical kit so two products will be listed. The second product is the 8mm drill included in a kit and It is labeled as OFKIT2 OsseoFix System Complete (Kit)3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL 33410 Non Sterile Contents must be sterilized prior to use. RX only.

    Recall: Z-0924-03 · Initiated May 9, 2003

    Recall

    Recall Number
    Z-0924-03
    Event Number
    26370
    Firm
    Implant Innovations, Inc.
    FEI Number
    1038806
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 9, 2003
    Posted
    June 17, 2003
    Terminated
    May 3, 2012
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410

    Description

    Products are surgical drills packaged separately or included in a surgical kit so two products will be listed. The second product is the 8mm drill included in a kit and It is labeled as OFKIT2 OsseoFix System Complete (Kit)3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL 33410 Non Sterile Contents must be sterilized prior to use. RX only.

    Reason

    Some 8mm OsseoFix drills may be incorrectly laser marked as 4mm OsseoFix drills.

    Action

    The firm faxed and e-mailed a recall communication to international accounts on 5/9/2003 and mailed recall letters to domestic accounts on 5/12/2003. The firms were requested to examine their stock and return product as well as to notify any subaccounts of the recall and recover and return their products. Letters to specific consignees only listed the recalled lot numbers that were shipped to that consignee. A response form was included and was to be faxed back to the recalling firm.

    Distribution

    Nationwide & France, Japan, Spain, Germany, Korea, Australia, Argentina, Denmark, Chile, England, Brazil.

    Quantity

    15