| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00902-1 |
| Product Name/Description |
Zimmer Trabecular Metal Reverse Glenosphere Distractor
(Supplied as part of the reusable instrumentation kit for shoulder replacement surgery)
Item number: 00-4309-049-00
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 Distractor due to the potential of the device not functioning properly should it be utilised without proper lubrication. As a result, there is a potential for the device to fail to provide impact to the Glensophere when the trigger is pulled. In addition, there is a potential for the foot of the device to fracture during use which may result in the device being unable to remove the Glenosphere. |
| Recall Action |
Recall |
| Recall Action Instructions |
Zimmer is requesting users to remove affected lots from use. Zimmer are replacing affected stock with replacement product which incorporates a new design. |
| Contact Information |
1800 803 263 - Zimmer Customer Service |