Recall Z-2261-2015— Otto Bock Healthcare GmbH
Class II · Terminated
Class II FDA medical device recall by Otto Bock Healthcare GmbH, initiated 2015-07-16, terminated 2017-06-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Otto Bock Healthcare GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-16
- Terminated
- 2017-06-21
- Firm location
- Duderstadt, N/A, Germany
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.