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SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packag...

FDA Recall #Z-0922-2014 — Class II — December 13, 2013

Recall #Z-0922-2014 Date: December 13, 2013 Classification: Class II Status: Terminated

Product Description

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.

Recalling Firm

Highland Metals, Inc. — San Jose, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

9 packages of each lot number.

Distribution

Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada.

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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