Highland Metals, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0922-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 13, 2013

Date Posted: February 12, 2014

Recall Number: Z-0922-2014

Event ID: 67378

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.

Status: Terminated

Product Quantity: 9 packages of each lot number.

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.

Voluntary or Mandated:

Voluntary: Firm initiated