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/ 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 2 |
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
|
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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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