Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Copper NiTi Preformed Archwires Recalled by Ormco/Sybronendo Due to Ormco Corporation is recalling Copper NiTi Preformed Archwires...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ormco/Sybronendo directly.
Affected Products
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
Quantity: 161 units
Why Was This Recalled?
Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ormco/Sybronendo
Ormco/Sybronendo has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report