Events

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
    Recall
  • Event ID
    72960
  • Event Risk Class
    Class 2
  • Event Number
    Z-0608-2016
  • Event Initiated Date
    2016-01-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142592
  • 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.

Device

Device Recall Modular Polycentric EBS Knee Joint
  • Model / Serial
    All serviced between 27 April 2015 and 17 November 2015
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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
    Otto Bock Healthcare GmbH

Manufacturer

Otto Bock Healthcare GmbH
  • Manufacturer Address
    Otto Bock Healthcare GmbH, Max-Nader-Str. #15, Duderstadt Germany
  • Manufacturer Parent Company (2017)
    Otto Bock Holding Gmbh & Co. Kg
  • Source
    USFDA