| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00154-1 |
| Product Name/Description |
Cup Removal Instruments (Reusable surgical instrument used to remove an acetabular cup with minimal loss of bone)
Multiple Product Codes |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
Device Technologies Australia has become aware that the packaging of the Cup Removal Instruments may not provide a sufficient safety barrier when handling and transporting instruments. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The distributors are advised to identify and isolate affected product from use, making sure to handle carefully. A Device Technologies Australia Pty Ltd's representative will contact the distributor to organise a time to repackage affected stock at their site. This re-packaging will consist of:
? Adding a new black cap to the blade
? Wrapping the blade head in bubble wrap and securing with tape.
? Re-packaging in the original packaging
? Addition of a warning sticker
? Addition of compliant labelling |
| Contact Information |
1800 429 551 - Device Technologies |