| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01512-1 |
| Product Name/Description |
3R62 Pheon Modular Knee Joint (External leg prosthesis)
Serial Numbers: 201447012, 201512056, 201517011
ARTG Number: 113606 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
22/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been found that the locking function may fail under certain conditions. The activation locking can only be activated by the clinician prior to the fitting of the device. The units that have been supplied in Australia do not have the locking mechanism activated. Please note that when the locking mechanism is set as non-active, the device poses no safety risk to the patient. However, it is possible that in the course of time the patient’s physical condition may require the locking function to be activated. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Otto Back is advising clinicians to contact patients who have been fitted with the affected device for a replacement with the new version.
This action has been closed out on the 12/10/2018. |
| Contact Information |
03 9439 9917 - Otto Bock |