Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
This recall has been terminated (originally issued November 30, 2015).
- Company
- Ormco/Sybronendo
- Recall Initiated
- November 4, 2015
- Posted
- November 30, 2015
- Terminated
- January 19, 2016
- Recall Number
- Z-0343-2016
- Quantity
- 161 units
- Firm Location
- Glendora, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
Distribution
Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.
Lot / Code Info
Lot No. 21538339
Root Cause
Employee error
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.