Copper NiTi Preformed Archwires — Class II medical device recall Z-0343-2016
Terminated recall by Ormco/Sybronendo, reported 2015-12-09, distributed nationwide. Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature
| Recall number | Z-0343-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ormco/Sybronendo, Glendora, CA, United States |
| Recall initiated | 2015-11-04 |
| Classified | 2015-11-30 |
| Reported by FDA | 2015-12-09 |
| Terminated | 2016-01-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP, MX, PE, RU |
| Quantity | 161 units |
| Reason classes | labeling |
| Lot numbers | 21538339 |
| Model numbers | 211-0952 |
Product
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
Reason for recall
Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
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-0343-2016. 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.