| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01135-1 |
| Product Name/Description |
APC Plus Victory Series Twin Upper Left Cuspid -3T/10A with Distal Hook (Unitek Orthodontic Metal Brackets - Orthodontic bracket, metal)
ARTG Number: 219341 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
21/10/2014 |
| Responsible Entity |
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| Reason/Issue |
Product content did not match label. A total of 20 boxes (each box contains 5 brackets) of ""APC Plus Victory Series Twin Upper Left Cuspid -3T/10A with Distal Hook, slot size 022"" with lot # FT1DG were supplied to 3 orthodontists (end user) in Australia in the period 28 July 2014 - 7 August 2014. Outer pack label packaging and individual blisters were labelled correctly. The type of bracket supplied within the blister was not correct. The incorrect bracket was ""APC Plus Victory Series Twin Upper Left/Right 1st Bicuspid with no hook"" instead of ""APC Plus Victory Series Twin Upper Left Cuspid -3T/10A with Distal Hook, slot size 022"". |
| Recall Action |
Recall |
| Recall Action Instructions |
This action was undertaken prior to approval of the recall strategy by the TGA.
Orthodontists supplied with the affected lot were notified. Orthodontists returned affected lots and 19 of the 20 boxes were received. 1 box was not returned. The retrieval rate was 95 %. All products returned were in the original packaging (unopened). |
| Contact Information |
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