FDA-Device2018-02-21Class II
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.
Aesculap Implant Systems LLC
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.
Sold states
USA (nationwide)
Affected count
13 Units
Manufactured in
3773 Corporate Pkwy, Center Valley, PA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0591-2018Don't want to check this manually?
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