BEUDAMED
    FDA Recall Terminated

    Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45

    Recall: Z-0043-2007 · Initiated September 12, 2006

    Recall

    Recall Number
    Z-0043-2007
    Event Number
    36362
    Firm
    Bioplate Inc
    FEI Number
    1000518793
    Product Code
    JEY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 12, 2006
    Posted
    October 19, 2006
    Terminated
    September 14, 2011
    Address
    3643 Lenawee Ave, Los Angeles, CA, 90016-4310

    Description

    Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45

    Reason

    Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.

    Action

    Customers were notified via telephone initially on 09/14/2006 to return product, and this was followed up within two days with a certified mail/return receipt required, recall notification letter. 100% of the consignees will be notified of the recall. Bioplate will fax and call non-responsive customers afler 5 days via telephone call. Customers not responding to the first recall notification will be sent a second notification certified mail recall notification.

    Distribution

    Nationwide to: CA, DC, GA, MI, OH, & PA

    Quantity

    36 units