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.
Check against the official notice below — it lists the full affected range.
Highland Metals, Inc. is recalling SuperElastic Regular force NiTi lower or upper Natural arches in 0.14 size, available in 10 or 100 count packages. The recall involves a labeling issue where packages labeled as "Upper" may actually contain "Lower" archwires with a red midline mark, and packages labeled as "Lower" may actually contain "Upper" archwires with a black midline mark. The affected products were distributed worldwide, including to locations in the USA (Illinois, Kentucky, Michigan, New York, California, Florida, and Louisiana) and internationally to Switzerland, Denmark, Greece, Australia, England, and Canada. A total of 37 packages across three lot numbers are involved in this recall.
The recall affects orthodontic archwires that are used to provide force during orthodontic treatment. Because the labeled and actual product types do not match, the wrong type of archwire could be used in patient treatment. The source document does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada. Quantity: 37 packages Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.