Titanium Orthos Brackets — Class II medical device recall Z-1321-2014
Terminated recall by Ormco/Sybronendo, reported 2014-04-09. Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121
| Recall number | Z-1321-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ormco/Sybronendo, Glendora, CA, United States |
| Recall initiated | 2014-03-25 |
| Classified | 2014-04-02 |
| Reported by FDA | 2014-04-09 |
| Terminated | 2014-10-27 |
| Countries outside the US | CA |
| Quantity | 150 units |
| Lot numbers | 121359169 |
| Model numbers | 449-6212 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1321-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.