Home / Recalls / Highland Metals, Inc. / Z-0922-2014

Z-0922-2014 Class II Terminated

Recalled by Highland Metals, Inc. — San Jose, CA

Recall Details

Product Type: Devices
Report Date: February 12, 2014
Initiation Date: December 13, 2013
Termination Date: February 4, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9 packages of each lot number.

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.

Distribution Pattern

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