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Recall Observatory FDA recall evidence

Device 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.

Z-0922-2014

December 13, 2013

Class II

Product summary

Firm
Highland Metals, Inc.
Event
Event 67378
Status
Terminated
Classification
Class II
Quantity
9 packages of each lot number.
Official record key
device-enforcement:Z-0922-2014

Official wording

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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.