Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2 Recalled by Otto Bock Healthcare Product Due to Otto Bock Healthcare Products GmbH is recalling the...

Date: August 12, 2015
Company: Otto Bock Healthcare Product
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Otto Bock Healthcare Product directly.

Affected Products

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.

Quantity: 1

Why Was This 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.

Where Was This Sold?

This product was distributed to 1 state: OH

Affected (1 state)Not affected

About Otto Bock Healthcare Product

Otto Bock Healthcare Product has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report