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.
FDA Recall Z-0143-2012 · Posted 2011-11-01
Recalling FirmBioplate Inc
Recall StatusTerminated
Product CodeJEY
Date Initiated2010-03-31
Date Terminated2012-04-04
Product Quantity16,020 Individual Kits; 2,226 Boxes.
Reason for Recall
There is potential defect in seal of the sterile barrier containing the device.
Firm 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.
Root Cause
Process design
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Canada, Europe, Japan, Taiwan, Middle East and Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.