Z-0343-2016 Class II Terminated
FDA device recall Z-0343-2016 was initiated by Ormco/Sybronendo on November 4, 2015 and is designated Class II. Reason for recall: Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect. The recall status is terminated (terminated January 19, 2016). Affected quantity: 161 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2015
- Initiation Date
- November 4, 2015
- Termination Date
- January 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 161 units
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.
Distribution Pattern
Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.
Code Information
Lot No. 21538339