Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corpora
FDA device recall Z-0916-2008 · posted 2008-04-10 · Terminated
Recall details
- Recalling firm
- Ormco Corporation
- Reason for recall
- Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07.
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DYH
- Quantity affected
- 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.
- Date initiated
- 2007-10-31
- Date posted
- 2008-04-10
- Date terminated
- 2012-03-22
- Location
- Glendora, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GRENGLOO (K061481) | Ormco Corp. | 2006-07-06 |