Highland Metals, Inc.: 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.

Agency Publication Date: February 3, 2014

Affected Products

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.

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

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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.

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

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 67378

Status: Resolved

Manufacturer: Highland Metals, Inc.

Manufactured In: United States

Units Affected: 2 products (9 packages of each lot number.; 37 packages)

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Sources: FDA iRES · Raw API Response

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Affected Products

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