Recall Z-0309-05 ยท EJF Bracket, Metal, Orthodontic
Ormco Corporation
Titanium Orthos Bracket
| Date | Dec 15, 2004 (initiated Nov 18, 2004) |
| Status | Terminated |
| Reason | Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed. |
| Root cause | Other |
| Action | Recall letters were mailed from 11/18 thru 11/23. Letters request return of product. |
| Quantity | 6,257 |
| Distribution | Nationwide and France, Luxembourg, Spain, Netherlands, Russia, Ireland, Italy, Germany, United Kingdom, Hungary, Finland, Denmark. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.