Ormco/Sybronendo recalls Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth mov…

Recall date

November 4, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0343-2016

FDA classification

Class II

Brand / firm

Ormco/Sybronendo

Sold / distributed

Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.

Why it was recalled

Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.