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

Recalled September 2, 2015 · FDA recall Z-2438-2015 · Otto Bock Healthcare Product

Hazard

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. · FDA Class II

Units

Sold at

Distributed to the state OH.

Description

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.

Product

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.

Manufacturer(s)

Otto Bock Healthcare Product

Made in

Austria

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →