Recall of Orthopedic Template

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aesculap Implant Systems LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Template - Product Code HWT
  • 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.
  • Action
    On August 21, 2017 an Urgent Medical Device Recall notification was issued titled "NS357R Tibia Trial Plateau" asking distributors to inspect Sets #0468 and follow the inspection instructions on the customer notification letter and immediately remove the affected part and return to Aesculap Implant Systems. Questions or concerns can be directed to Customer Service at 314-551-5998


  • Model / Serial
    The product is located in the Vega Tibia preparation Tray (NS803) in the Vega Instrument Set (ST0468).
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    USA (nationwide)
  • 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.
  • Manufacturer


  • Manufacturer Address
    Aesculap Implant Systems LLC, 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Manufacturer Parent Company (2017)
  • Source