Device product
Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.
Z-2261-2015
Product summary
- Event
- Event 71715
- Status
- Terminated
- Classification
- Class II
- Quantity
- 518 (439 US; 79 OUS)
- Official record key
device-enforcement:Z-2261-2015
Official wording
Reason: Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distributed since February 2014 because the locking function may fail under certain conditions which may result in a fall.
Code information: The removal affects all devices manufactured and distributed since February 2014.
Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: AU, BE, CN, CZ, IT, NL, and SK.
Derived failure modes
-
Unknown
Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distributed since February 2014 because the locking function may fail under certain conditions which may result in a fall.