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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 Smith & Nephew Pty Ltd
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 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