Otto Bock Healthcare GmbH recalls Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for low…

Recall date

July 16, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2261-2015

FDA classification

Class II

Brand / firm

Otto Bock Healthcare GmbH

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: AU, BE, CN, CZ, IT, NL, and SK.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.