Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4211 Lot Number 100514071 and 100512012
FDA device recall Z-0204-06 · posted 2005-11-26 · Terminated
Recall details
- Recalling firm
- Ormco Corporation
- Reason for recall
- Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
- Action taken
- Telephone notification will be followed by letters sent via U.S. first class mail with mailing to commence on Thursday, 11/3/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYW
- Quantity affected
- 1420
- Distribution
- Nationwide
- Date initiated
- 2005-11-03
- Date posted
- 2005-11-26
- Date terminated
- 2006-01-11
- 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 |
|---|---|---|
| DAMON 3 MODIFIED (K052477) | Ormco Corp. | 2005-11-30 |