Home / Recalls / Otto Bock Healthcare Product / Z-2438-2015

Z-2438-2015 Class II Terminated

Recalled by Otto Bock Healthcare Product — Wien, N/A

Recall Details

Product Type: Devices
Report Date: September 2, 2015
Initiation Date: August 12, 2015
Termination Date: October 28, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Distributed to the state OH.

Code Information

Serial Number 201528049, manufactured on 01 July 2015