Highland Metals, Inc.: 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

Is my product affected?

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.

• UPC 11100161124
• UPC 11100161125
• UPC 11100161144

Check against the official notice below — it lists the full affected range.

What happened

Highland Metals, Inc. is recalling SuperElastic Regular force NiTi lower or upper Natural arches in 0.16 size, distributed worldwide to locations including the United States (Illinois, Kentucky, Michigan, New York, California, Florida, Louisiana) and internationally to Switzerland, Denmark, Greece, Australia, England, and Canada. The recall affects nine packages of each of three lot numbers due to a labeling issue: 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 recall involves part numbers 11100161124, 11100161125, and 11100161144. The source document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: 9 packages of each lot number. Lot/code info: Part Number Part Description Lot Number Label Form Actual Form 11100161124 SE Niti 016 Nat U 100 41684 Upper Lower 11100161125 SE Niti 016 Nat U 10 41684 Upper Lower 11100161144 SE Niti 016 Nat L 100 41679 Lower Upper

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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