Highland Metals Recalls SuperElastic NiTi Archwires Due to Labeling Errors
Highland Metals, Inc. is recalling SuperElastic NiTi archwires because some packages labeled 'Upper' contain 'Lower' archwires and vice versa.
What this means for you
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: This is a Class II recall involving a labeling error that could lead to incorrect device usage, but no injuries or illnesses are reported in the source text.
Plain-English summary
Highland Metals, Inc. is recalling specific packages of SuperElastic Regular force NiTi lower or upper Natural arches, size 0.16, in 10 or 100 count packages. The recall involves 9 packages of each affected lot number. The devices are intended to provide force to teeth to effect movement in order to alter their position.
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 part numbers are 11100161124, 11100161125, and 11100161144, with lot number 41684 or 41679.
The affected 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. 0.16 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.
- Manufacturer
- Highland Metals, Inc.
- Category
- Medical Device — Orthodontic
- Hazard
- Affected units
- 9
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
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