Highland Metals, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0923-2014)

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. 0.14 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.

Product Classification:

Class II

Date Initiated: December 13, 2013

Date Posted: February 12, 2014

Recall Number: Z-0923-2014

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: 37 packages

Code Information:

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

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