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Ormco/Sybronendo recalls Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth mov
Recalled December 9, 2015 · FDA recall Z-0343-2016 · Ormco/Sybronendo
Hazard
Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect. · FDA Class II
Units
161 units
Sold at
Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.
Description
Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
Product
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
Manufacturer(s)
Ormco/Sybronendo
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →