Recall Z-0343-2016— Ormco/Sybronendo

Name: FDA recall Z-0343-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-04

Class II · Terminated

Class II FDA medical device recall by Ormco/Sybronendo, initiated 2015-11-04, terminated 2016-01-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.. Reason: Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect..

Recalling firm: Ormco/Sybronendo
Classification: Class II
Status: Terminated
Initiated: 2015-11-04
Terminated: 2016-01-19
Firm location: Glendora, CA, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.