Class 2 Device Recall Bioplate Resorbable Bone

• Date Initiated by Firm: September 12, 2006
• Date Posted: October 19, 2006
• Recall Status: Terminated 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
• FEI Number: 1000518793
• Recalling Firm/ Manufacturer: Bioplate Inc; 3643 Lenawee Ave; Los Angeles CA 90016-4310
• For Additional Information Contact: Jeannie L. Denning ASQ CQA; 951-672-1060
• 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: Other
• 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