| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00901-1 |
| Product Name/Description |
Zimmer Trabecular Metal Reverse Glenosphere Helmet, 36mm/40mm
(Supplied as part of the reusable instrument kit for shoulder replacement surgery)
Item numbers: 00-4309-071-36 and 00-4309-071-40
Multiple lot numbers affected
ARTG Number: 109936 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer is initiating a recall of the Trabecular Metal Reverse Glenosphere Helmets due to the potential of one or both tabs fracturing during use. As a result, there is a potential for the tab to become disassociated from the device.
|
| Recall Action |
Recall |
| Recall Action Instructions |
Zimmer is requesting users to remove affected lots from use. A replacement product will be provided by Zimmer which incorporates a new design. |
| Contact Information |
1800 803 263 - Zimmer Customer Service |