Copper NiTi Preformed Archwires recall: Labeling Error
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
Why was Copper NiTi Preformed Archwires recalled?
Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot No. 21538339
- Product
- Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
- Recalling firm
- Ormco/Sybronendo
- Quantity
- 161 units
- Distribution
- Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.
- Recall date
- December 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)