Events

Recall of Excia Cemented Hip Stems

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

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
    45456
  • Event Risk Class
    Class 2
  • Event Number
    Z-0443-2008
  • Event Initiated Date
    2007-10-10
  • Event Date Posted
    2007-12-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65498
  • 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
    Hip Stems - Product Code LWJ
  • Reason
    Sterility (package integrity) compromised: device package damaged during shipment.
  • Action
    The recalling firm issued an Important Recall Notice letter dated 10/10/07 to all their customers informing them of the problem and the need to return the product.

Device

Excia Cemented Hip Stems
  • Model / Serial
    All Lot Numbers
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide-USA including states of AZ, GA, MD, OK, PA, TX, and VA (distributors) medical facilities in FL, NY, and PA; and sales representatives in CA and FL.
  • Product Description
    Excia Cemented Hip Stems ,Size 18mm, Part Number NJ318K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
  • Manufacturer
    Aesculap Implant Systems

Manufacturer

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