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U.S. Department of Health and Human Services

Class 2 Device Recall Bioplate Resorbable Bone

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  Class 2 Device Recall Bioplate Resorbable Bone see related information
Date Initiated by Firm September 12, 2006
Date Posted October 19, 2006
Recall Status1 Terminated 3 on September 14, 2011
Recall Number Z-0043-2007
Recall Event ID 36362
510(K)Number K051845  
Product Classification Bone Fixation - Product Code JEY
Product Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
Code Information Lot number: S29640905
Recalling Firm/
Bioplate Inc
3643 Lenawee Ave
Los Angeles CA 90016-4310
For Additional Information Contact Jeannie L. Denning ASQ CQA
Manufacturer Reason
for Recall
Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.
FDA Determined
Cause 2
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.
Quantity in Commerce 36 units
Distribution Nationwide to: CA, DC, GA, MI, OH, & PA
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.