Recall Z-0343-2016 ยท DZC Wire, Orthodontic
Ormco/Sybronendo
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
| Date | Nov 30, 2015 (initiated Nov 4, 2015) |
| Status | Terminated |
| Reason | Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect. |
| Root cause | Employee error |
| 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. |
| Quantity | 161 units |
| Distribution | Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.