| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01068-1 |
| Product Name/Description |
UNIVERSAL Modular Electric/Battery Double Trigger Handpiece (Surgical power tool)
Model number: 89-8507-400-00
ARTG Number 215808 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Surgical identified a potential malfunction on the UNIVERSAL Modular Electric/Battery Double Trigger Handpiece. It is possible that the handpiece could start by itself when the power source is connected. The unexpected output of the device (start by itself) could lead to an injury to the user during usage or preparation of the device. The complaint rate for this occurrence is 0.5% per distributed device, and no injuries have been reported. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
To avoid this potential issue (malfunction), Zimmer Surgical is advising customers to implement temporary workaround instructions through the customer letter. Zimmer Surgical, as part of the annual preventive maintenance activities, will upgrade the devices with the new electronics that prevent the “self-start” issue and may also exchange other components as appropriate during the preventive maintenance check. This action has been closed-out on 06/06/2016. |
| Contact Information |
1800 803 263 - Zimmer Customer Service |