| 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 |
|
| 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 http://www.tga.gov.au/safety/alerts-device-hip-dac-121030.htm |
| Contact Information |
02 9950 5470 - Zimmer Regulatory Affairs |