FDA-Device2015-12-09Class II
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
Ormco/Sybronendo
Hazard
Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
Sold states
Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.
Affected count
161 units
Manufactured in
1332 S Lone Hill Ave, Glendora, CA, United States
Products
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0343-2016Don't want to check this manually?
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