| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00973-1 |
| Product Name/Description |
Aequalis Ascent Flex Reversed Cut Guide (Instrument for use in the implantation of joint prostheses)
Item Number: MWF011
Lot Number: DP0213287
ARTG Number: 112287 |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
Tornier SAS has identified that some Reversed Cut Guides have been incorrectly assembled during the manufacturing process. A faulty guide will generate an incorrect version measurement and may cause confusion or an improper humeral head resection. All the parts affected come from the same lot number (DP0213287).
|
| Recall Action |
Recall |
| Recall Action Instructions |
Tornier Pty Ltd have all the affected products within their warehouses or their distributors warehouses. Tornier is checking the stock or requesting the distributors to check the stock and if faulty guides are identified, will replace the faulty guides with new ones.
This action was undertaken prior to consultation with the Therapeutic Goods Administration. |
| Contact Information |
02 9451 2244 - Tornier |