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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 Otto Bock Australia Pty Ltd
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