Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
FDA Recall Z-0343-2016 · Posted 2015-11-30
Recalling FirmOrmco/Sybronendo
Recall StatusTerminated
Product CodeDZC
Date Initiated2015-11-04
Date Terminated2016-01-19
Product Quantity161 units
Reason for Recall
Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
Firm Action
A recall letter dated 11/5/15 was sent to all their customers who purchased the Copper NiTi Preformed Archwires because it has been brought to Ormco's attention that the product transformation temperature as listed on the labeling is incorrect. The wire is labeled as having 40 degrees Celsius transformation temperature, but the actual wire has a transformation temperature of 29 degrees Celsius. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to complete and fax back the enclosed acknowledgement form.
Root Cause
Employee error
Distribution Pattern
Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.