FDAAugust 12, 2015device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
otto bock healthcare productottootto bock
Recall history
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