Recall of Device Recall Modular Polycentric EBS Knee Joint

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Otto Bock Healthcare GmbH.

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 Status
  • Event Country
  • Event Terminated Date
  • 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
    Joint, knee, external limb component - Product Code ISY
  • Reason
    Otto bock healthcare gmbh is recalling modular polycentric ebs knee joint that were serviced between 27 april 2015 and 17 november 2015 due to a service error where the wrong loctite was used during repair.
  • Action
    Starting Jan 4 2016, In coordination with the Manufacturer, the US Agent will notify customers via telephone call of the correction on behalf of the Manufacturer. The customers will be requested to return the affected devices back to the service center for correction. The devices will be returned to the customer following correction.


  • Model / Serial
    All serviced between 27 April 2015 and 17 November 2015
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution.
  • Product Description
    Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.
  • Manufacturer


  • Manufacturer Address
    Otto Bock Healthcare GmbH, Max-Nader-Str. #15, Duderstadt Germany
  • Manufacturer Parent Company (2017)
  • Source