Otto Bock Healthcare Product recalls Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Inte…

Recall date

August 12, 2015

Source

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

Recall number

Z-2438-2015

FDA classification

Class II

Brand / firm

Otto Bock Healthcare Product

Sold / distributed

Distributed to the state OH.

Why it was recalled

Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to issues with the resistance-control of the hydraulics, which may fail under conditions.

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

What was recalled

Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings.