Recall Z-0916-2008 ยท DYH Adhesive, Bracket And Tooth Conditioner, Resin
Ormco Corporation
Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740
| Date | Apr 10, 2008 (initiated Oct 31, 2007) |
| Status | Terminated |
| Reason | Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061481 | GRENGLOO Ormco Corp., Jul 6, 2006 |