Events

Recall of Aesculap Arcadius Trial Insertion Instrument (ME020R/ME020RUS)

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

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
    Recall
  • Event ID
    66534
  • Event Risk Class
    Class 2
  • Event Number
    Z-0361-2014
  • Event Initiated Date
    2013-09-20
  • Event Date Posted
    2013-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122557
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    The trial insertion instrument may disassemble during use due to a potentially weak weld on then trial inserter shaft block area located near the thumb wheel.
  • Action
    An Important Product Removal Notification dated September 20, 2013 was sent to customers.

Device

Aesculap Arcadius Trial Insertion Instrument (ME020R/ME020RUS)
  • Model / Serial
    model no. ME020R
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) GA, TN, CA, WY, NV, TX, OK, OH, and IL; and internationally to Canada.
  • Product Description
    Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
  • Manufacturer
    Aesculap, Inc.

Manufacturer

Aesculap, Inc.
  • Manufacturer Address
    Aesculap, Inc., 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA