Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01337-1
Product Name/Description	SuperElastic NiTi Archwires (intended to provide force to the teeth to effect movement in order to alter their position) SE Niti 014 Nat U 100 Part Number: 11100141124 Lot Number: 41756 SE Niti 014 Nat L 100 Part Number: 11100141144 Lot Number: 41760 ARTG Number: 165070
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	18/12/2013
Responsible Entity	Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue	The manufacturer has initiated a recall due to a product mislabelling which may result in inefficient treatment of the patient and could require further medical intervention to replace the wire. - Product labelled as “Upper” may contain “Lower” archwires with a red midline mark - Product labelled as “Lower” may contain “Upper” archwires with a black midline mark
Recall Action	Recall
Recall Action Instructions	Emergo is advising users to return affected devices for replacement.
Contact Information	02 9006 1662 - Emergo Australia