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U.S. Department of Health and Human Services

Class 2 Device Recall Bioplate Titanium Fixation System, Sterile Kit.

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  Class 2 Device Recall Bioplate Titanium Fixation System, Sterile Kit. see related information
Date Initiated by Firm March 31, 2010
Date Posted November 01, 2011
Recall Status1 Terminated 3 on April 04, 2012
Recall Number Z-0143-2012
Recall Event ID 55537
510(K)Number K082757  
Product Classification Plate, bone - Product Code JEY
Product 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.
Code Information Product Code Lot # 81-2093 G03411108  G03680409  81-2094 G03421108  G03690409  81-3573 1000  1002   1527  G03251108  G03630409  G03920709  81-3574 G03391108  G03650409  81-3575 1004  1543  G03261108  G03431208  G03660409  G03740509  G03880709  81-3576 1244  1561  G03221108  G03670409  81-3577 G03231108  G03640409  G03820609  G03890709  81-3578 1075  1690  G03241108  G03830609   81-3579 1167  1562  G03401108  G03450109  81-3580 185  G03211108  G03460109  G03590309  G03840609  81-3581 414  1034  1524  1894  G03201108  G03600309  G03750509  G03870609  G03900709  81-3582 993  1220  1692  G03331108  G03770509  G03910709  81-3583 G03271108  G03790509  81-3584 G03341108  G03850609  81-3585 G03351108  G03610309  81-3586 1005  G03371108  81-3587 G03361108  81-3588 1812  G03381108  G03860609  81-3590 G03311108  G03440109  G03550209  81-3591 1637  1816  G03321108  G03480109  G03560209  G03620309  81-3592 1069  G03490109  G03570209  G03780509  81-3593 1070  G03470109  81-5888 1813  81-5890 1043  81-5894 G03281108  81-5895 1023  1227  1240  1817  G03291108  81-5896 G03301108   81-5900 1814  G03700409  81-5901 G03710409  81-5902 G03720409  81-5903 1818  G03730409  G03760509
Recalling Firm/
Manufacturer		 Bioplate Inc
3643 Lenawee Ave
Los Angeles CA 90016-4310
For Additional Information Contact Chelsea Mitchell
310-815-2126
Manufacturer Reason
for Recall		 There is potential defect in seal of the sterile barrier containing the device.
FDA Determined
Cause 2		 Process design
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.
Quantity in Commerce 16,020 Individual Kits; 2,226 Boxes.
Distribution Worldwide Distribution - USA (nationwide) and the countries of Canada, Europe, Japan, Taiwan, Middle East and Australia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JEY and Original Applicant = BIOPLATE, INC.
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