Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
Reported: December 9, 2015 Initiated: November 4, 2015 #Z-0343-2016
Product Description
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
Reason for Recall
Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
Details
- Recalling Firm
- Ormco/Sybronendo
- Units Affected
- 161 units
- Distribution
- Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.
- Location
- Glendora, CA
Frequently Asked Questions
What product was recalled? ▼
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.. Recalled by Ormco/Sybronendo. Units affected: 161 units.
Why was this product recalled? ▼
Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 9, 2015. Severity: Moderate. Recall number: Z-0343-2016.
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