Events

Recall of Polarstem Cardan for 21000438

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00927-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00927-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

Polarstem Cardan for 21000438
  • Model / Serial
    Polarstem Cardan for 21000438Model Number: 75102260Batch Number: A59547ARTG Number: 181339
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd