Events

Recall of Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5F7

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
    66536
  • Event Risk Class
    Class 2
  • Event Number
    Z-0492-2014
  • Event Initiated Date
    2013-09-19
  • Event Date Posted
    2013-12-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122560
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    The columbus revision cocr 15 mm distal and posterior implant spacers, sizes f5-f7, were not compatible.
  • Action
    Domestic consignees were contacted by phone and a recall notification letters was also sent to these Users on/about September 26, 2013.

Device

Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5F7
  • Model / Serial
    lots: 51468773, 51447588, 51468302, 51503760, 51571394, 51585136, 51447597
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in FL and MD.
  • Product Description
    Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7
  • 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