Reported Sep 2, 2015 · Terminated

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

Otto Bock Healthcare Product

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Otto Bock Healthcare Product · Brehmstrasse 16 · Wien, N/A · N/A

Is this the product you have?

  • Otto Bock Healthcare
  • Products GmbH Genium X3 Model Number3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings
Lot codes and dates
    • Serial Number 201528049
    • manufactured on 01 July 2015
Amount recalled
1

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 28, 2015 · Data as of Sep 19, 5:30 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.