| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00162-1 |
| Product Name/Description |
VDR Proximal Targeting Guide in Acu-Loc 2 Loan sets
Part Numbers: 80-0700 (yellow), 80-0702 (yellow), 80-0704 (yellow), 80-0701 (yellow), 80-0703 (yellow), 80-0705 (yellow)
Manufactured prior to 28 August 2012
ARTG Number: 97308 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
There is a chance that the VDR Proximal Targeting Guide will crack and/or break after repeated use in surgery. If the instrument breaks, it may result in pieces not being removed from the patient and therefore causing prolonged surgery, soft tissue damage, histological and/or allergic reaction. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medical and Optical are advising users that all affected devices are being replaced with "black" guides unaffected by this issue. |
| Contact Information |
1800 225 065 - Medical + Optical Instruments Australia Pty Ltd |