Recall Z-0204-06 ยท DYW Bracket, Plastic, Orthodontic
Ormco Corporation
Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4211 Lot Number 100514071 and 100512012
| Date | Nov 26, 2005 (initiated Nov 3, 2005) |
| Status | Terminated |
| Reason | Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance. |
| Root cause | Other |
| Action | Telephone notification will be followed by letters sent via U.S. first class mail with mailing to commence on Thursday, 11/3/05. |
| Quantity | 1420 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052477 | DAMON 3 MODIFIED Ormco Corp., Nov 30, 2005 |