Z-2261-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2015
- Initiation Date
- July 16, 2015
- Termination Date
- June 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 518 (439 US; 79 OUS)
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: AU, BE, CN, CZ, IT, NL, and SK.
Code Information
The removal affects all devices manufactured and distributed since February 2014.