| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00006-1 |
| Product Name/Description |
W & H Foot Control - S-N1/S-N2
Multiple Serial Numbers
ARTG 125363 (ADEC AUSTRALIA - Implantmed (various models) - Drill/saw system, dental) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
A-Dec has been made aware of a potential malfunction with certain W&H Foot controls. The foot control might not switch back to zero position when the pedal is released. Consequently, the motor keeps rotating. If this happens during automatic thread cutting or automatic screwing-in of implants, it can, in the worst case, lead to a serious injury of the patient.
So far, no incident has been reported. |
| Recall Action |
Recall |
| Recall Action Instructions |
A-Dec will contact affected customers to arrange replacement foot controls to be provided. In the interim, the affected products must not be used for thread cutting and screwing in of implants. These operations have to be conducted manually.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 8332 4000 - A-dec Australia |