Aesculap Implant Systems LLC: Medical Device Recall in 2018 - (Recall #: Z-0591-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 10, 2017

Date Posted: February 21, 2018

Recall Number: Z-0591-2018

Event ID: 79042

Reason for Recall:

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.

Status: Terminated

Product Quantity: 13 Units

Code Information:

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

Distribution Pattern:

USA (nationwide)

Voluntary or Mandated:

Voluntary: Firm initiated