Recall Z-0916-2008
Ormco Corporation · initiated October 31, 2007
Product
Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740
Codes / lots: Part Number 740-0322, Lot Number 2792584
Reason for recall
Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07.
FDA-determined cause: Process design
Action taken
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.
Details
- Recall number
- Z-0916-2008
- Initiated
- October 31, 2007
- Posted by FDA
- April 10, 2008
- Terminated
- March 22, 2012
- Product code
- DYH – Adhesive, Bracket And Tooth Conditioner, Resin
- Quantity
- 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.
- Recalling firm
- Ormco Corporation, Glendora, CA