SuperElastic Regular force NiTi lower or upper Natural arches — Class II medical device recall Z-0922-2014
Terminated recall by Highland Metals, Inc., reported 2014-02-12, distributed in CA, FL, IL, KY, LA, MI, NY. Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labe
| Recall number | Z-0922-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Highland Metals, Inc., San Jose, CA, United States |
| Recall initiated | 2013-12-13 |
| Classified | 2014-02-03 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2014-02-04 |
| Distributed | CA, FL, IL, KY, LA, MI, NY |
| Countries outside the US | AU, CA, CH, DK, GB, GR |
| Quantity | 9 packages |
| Reason classes | labeling |
Product
SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
Reason for recall
Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark.
Machine access
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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.