FDAAugust 10, 2017device
NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is implantation of the incorrect implant size which may lead to injury of ligaments, pain and possible revision surgery.
What to do
FDA enforcement status: Terminated
Brands named
aesculap implant systemsaesculapaesculap implant
Recall history
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