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

FDA device recall Z-0343-2016 · posted 2015-11-30 · Terminated

Recall details

Recalling firm

Ormco/Sybronendo

Reason for recall

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

Action taken

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

Status

Terminated

Product code

DZC

Quantity affected

161 units

Distribution

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

Date initiated

2015-11-04

Date posted

2015-11-30

Date terminated

2016-01-19

Location

Glendora, CA