FDA Device recall Z-0923-2014
SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages
- FDA Device
- Class II
- terminated
- Published 2014-02-12
On 2014-02-12 the FDA classified a Class II recall of SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages by Highland Metals, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0923-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-13 |
| Published | 2014-02-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Highland Metals |
| Distribution | CA, FL, IL, KY, LA, MI, NY |
Product
SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 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
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.
Identifiers
| code_info | Part Number Part Description Lot Number Label Form Actual Form 11100141124 SE Niti 014 Nat U 1…Part Number Part Description Lot Number Label Form Actual Form 11100141124 SE Niti 014 Nat U 100 41756 Upper Lower 11100141144 SE Niti 014 Nat L 100 41760 Lower Upper 11100141145 SE Niti 014 Nat L 10 41760 Lower Upper |
|---|
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-0923-2014%22
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