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 201528049manufactured 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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