Otto Bock Healthcare Product: Medical Device Recall in 2015 - (Recall #: Z-2438-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 12, 2015

Date Posted: September 2, 2015

Recall Number: Z-2438-2015

Event ID: 71950

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.

Status: Terminated

Product Quantity: 1

Code Information:

Serial Number 201528049, manufactured on 01 July 2015

Distribution Pattern:

Distributed to the state OH.

Voluntary or Mandated:

Voluntary: Firm initiated