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U.S. Department of Health and Human Services

Class 2 Device Recall Grengloo (Unidose Tips)

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  Class 2 Device Recall Grengloo (Unidose Tips) see related information
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.
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