Aesculap Implant Systems LLC recalls NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected par…

Recall date

August 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0591-2018

FDA classification

Class II

Brand / firm

Aesculap Implant Systems LLC

Sold / distributed

USA (nationwide)

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.