BEUDAMED
    FDA Recall Terminated

    Bioplate Titanium Fixation System, Sterile Kit. The sterile plate and screw kit configurations for use with the Bioplate Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant.

    Recall: Z-0143-2012 · Initiated March 31, 2010

    Recall

    Recall Number
    Z-0143-2012
    Event Number
    55537
    Firm
    Bioplate Inc
    FEI Number
    1000518793
    Product Code
    JEY
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 31, 2010
    Posted
    November 1, 2011
    Terminated
    April 4, 2012
    Address
    3643 Lenawee Ave, Los Angeles, CA, 90016-4310

    Description

    Bioplate Titanium Fixation System, Sterile Kit. The sterile plate and screw kit configurations for use with the Bioplate Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant.

    Reason

    There is potential defect in seal of the sterile barrier containing the device.

    Action

    BIOPLATE sent an URGENT - PRODUCT RECALL NOTIFICATION letter dated March 18, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return any recalled product they have at their site and if distributed further they should forward the information contained in the letter to all customers. If a device from one of the lots noted above has already been used, Bioplate would like to be advised of that use. They asked that consignees complete the enclosed Fax form and transmit the requested information to them as soon as possible at (310) 815-2126. Returned recalled product was to be sent to: Bioplate 3643 Lenawee Avenue Los Angeles, CA 90016 3643 Lenawee Avenue, Los Angeles, CA 90016 For any questions regarding this recall call (310) 815-2100.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Canada, Europe, Japan, Taiwan, Middle East and Australia.

    Quantity

    16,020 Individual Kits; 2,226 Boxes.