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Recall Observatory FDA recall evidence

Device product

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.

Z-0591-2018

August 10, 2017

Class II

Product summary

Firm
Aesculap Implant Systems LLC
Event
Event 79042
Status
Terminated
Classification
Class II
Quantity
13 Units
Official record key
device-enforcement:Z-0591-2018

Official wording

Reason: 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.

Code information: The product is located in the Vega Tibia preparation Tray (NS803) in the Vega Instrument Set (ST0468).

Distribution pattern: USA (nationwide)

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrectly labeled