FDA Device recall Z-1321-2014
Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169
- FDA Device
- Class II
- terminated
- Published 2014-04-09
On 2014-04-09 the FDA classified a Class II recall of Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169 by Ormco Sybronendo, citing ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1321-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-25 |
| Published | 2014-04-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ormco Sybronendo |
| Distribution | n/a |
Product
Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.
Reason
Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of the brackets.
Identifiers
| code_info | Part Number 449-6212, Lot Number 121359169. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1321-2014%22
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