FDA Enforcement
Class II
Terminated
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.
Recall: Z-2261-2015
·
Reported August 5, 2015
Enforcement
- Recall Number
- Z-2261-2015
- Event ID
- 71715
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Otto Bock Healthcare GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 5, 2015
- Initiation Date
- July 16, 2015
- Classification Date
- July 24, 2015
- Termination Date
- June 21, 2017
- Address
- Max-Nader-Str. #15, N/A, Duderstadt, N/A, N/A, Germany
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
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 Info
The removal affects all devices manufactured and distributed since February 2014.
Distribution
Worldwide Distribution: US (nationwide) and countries of: AU, BE, CN, CZ, IT, NL, and SK.
Quantity
518 (439 US; 79 OUS)