Date Initiated by Firm |
October 31, 2007 |
Date Posted |
April 10, 2008 |
Recall Status1 |
Terminated 3 on March 22, 2012 |
Recall Number |
Z-0916-2008 |
Recall Event ID |
46380 |
510(K)Number |
K061481
|
Product Classification |
Bracket adhesive resin and tooth conditioner - Product Code DYH
|
Product |
Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740 |
Code Information |
Part Number 740-0322, Lot Number 2792584 |
Recalling Firm/ Manufacturer |
Ormco Corporation 1332 S Lone Hill Ave Glendora CA 91740-5339
|
For Additional Information Contact |
Wendy Garman 714-516-7602
|
Manufacturer Reason for Recall |
Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07.
|
FDA Determined Cause 2 |
Process design |
Action |
Ormco sent fourteen (14) consignees Urgent Device Recall Notification via U.S. First Class mail on October 31, 2007. There were two (2) additional letters sent to the consignees in France that were translated into French. The consignees were instructed to complete the Return Form and return any affected product in their inventory. Periodic effectiveness checks will be conducted in order to follow up with non-responders. For more information, contact firm at 1-800-854-1741. |
Quantity in Commerce |
4 kits (Total US and Internationally) |
Distribution |
Worldwide Distribution-USA states of IL, NY, LA, CA, NJ, NV and SC and countries of Canada, France and South Africa. |
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 = DYH and Original Applicant = ORMCO CORP.
|