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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00907-1
Product Name/Description Durom Acetabular Component (Used for metal on metal hip replacements)

Previous ARTG Number: 100041
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 4/10/2012
Responsible Entity Zimmer Pty Ltd
Reason/Issue Zimmer Pty Ltd withdrew the Durom Acetabular Component from the Australian market, with effect from 30th June 2011, due to a decline in sales. A Hazard Alert is being issued in response to the TGA’s proposal to cancel the inclusion of the Durom Acetabular Component from the ARTG based on the devices cumulative revision rate of 9.6% at 7 years in resurfacing applications and 6.8% at 5 years for total conventional hip replacements as reported in the 2011 National Joint Replacement Registry (NJRR) report.
Recall Action Hazard Alert
Recall Action Instructions Zimmer is advising implanting/treating surgeons on how to manage patients implanted with Durom Acetabular Components. For more details, please see
Contact Information 02 9950 5470 - Zimmer Regulatory Affairs