| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00927-1 |
| Product Name/Description |
Polarstem Cardan for 21000438
Model Number: 75102260
Batch Number: A59547
ARTG Number: 181339 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Smith & Nephew have identified a design issue for a specific model/batch of Polarstem Cardan for 21000438. The affected cardan joint could potentially fracture or functionally fail after multiple procedures. In the event the Cardan breaks during use, the final implanted stem may have to be retrieved. This could potentially result in fragments of the broken components remaining in the wound. |
| Recall Action |
Recall |
| Recall Action Instructions |
Smith & Nephew is requesting Customers:
1. Immediately locate and quarantine affected devices;
2. If any of the recalled products could have been transferred from your hospital to another hospital please provide copies of the notice to all users informing them of the recall;
3. Please complete and sign and return the supplied Recall Acknowledgement Form with the number of affected devices you have to return, even if you have no products to return;
4. The acknowledgement form may be returned by email to RegulatoryAffairs.ANZ@smith-nephew.com or by fax on 1800 671 000 (Toll Free)
5. In the event customers have affected product to return, Smith & Nephew representatives will be in contact to arrange for affected products to be returned.
This action has been closed out on 21/09/2018 |
| Contact Information |
1800 671 000 - Smith & Nephew |