Ormco Recalls Copper NiTi Preformed Archwires Due to Incorrect Labeling
Ormco is recalling Copper NiTi Preformed Archwires because the transformation temperature listed on the label is incorrect.
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 due to a labeling error regarding the transformation temperature, which fits the rubric criterion for minor labeling errors.
Plain-English summary
Ormco Corporation is recalling Copper NiTi Preformed Archwires, Part No. 211-0952, because the product transformation temperature listed on the labeling is incorrect. The product is intended to provide tooth movement.
The recall involves 161 units from Lot No. 21538339. These archwires were distributed nationwide in the United States and in Canada, Japan, Mexico, Russia, and Peru.
Consumers and healthcare providers should stop using the affected archwires and contact Ormco Corporation for further instructions.
The recalled product
- Product
- Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
- Manufacturer
- Ormco/Sybronendo
- Category
- Medical Device — Orthodontic
- Hazard
- Affected units
- 161
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot No. 21538339
Distribution
Distributed nationwide across the United States.
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