Highland Metals Recalls SuperElastic NiTi Orthodontic Archwires Due to Labeling Errors
Highland Metals, Inc. is recalling SuperElastic NiTi orthodontic archwires because some packages are mislabeled, potentially containing the wrong arch type.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling error without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Highland Metals, Inc. is recalling 37 packages of SuperElastic Regular force NiTi lower or upper Natural arches in 0.14 size. The devices are intended to provide force to teeth to effect movement in order to alter their position. The recall involves 10 and 100 count packages.
The recall is due to a labeling issue where products labeled as "Upper" may contain "Lower" archwires with a red midline mark, and products labeled as "Lower" may contain "Upper" archwires with a black midline mark. The affected lot numbers are 41756 and 41760, with part numbers 11100141124, 11100141144, and 11100141145.
The products were distributed worldwide, including in the United States (IL, KY, MI, NY, CA, FL, LA) and internationally to Switzerland, Denmark, Greece, Australia, England, and Canada. Consumers and healthcare providers should stop using the affected archwires and contact Highland Metals, Inc. for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Highland Metals, Inc.
- Category
- Medical Device — Orthodontic
- Hazard
- Affected units
- 37
Distribution
Part of a larger recall action
This product is one of 2 recalled by Highland Metals, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Highland Metals, Inc.
See all →- ModerateHighland Metals Recalls SuperElastic NiTi Archwires Due to Labeling Errors
FDA (Devices) · 2014-02-12
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