Events

Recall of OTTO BOCK Kenevo knee joints

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

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
    79019
  • Event Risk Class
    Class 2
  • Event Number
    Z-0815-2018
  • Event Initiated Date
    2017-09-12
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161206
  • 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 products gmbh has identified a design issue through extended durability testing where the pylon clamping mechanism has the potential to cause damage to the pylon. when used longer than 1.45 million cycles (which represents approximately 2.3 years of use of the knee joint under heavy usage conditions), and the pylon clamp is overtightened according to the labeled torque specification, and the patient weighs at most 125kg it may be remote that the pylon breaks, and causing the patient to fall. there have been no failures or complaints reported directly attributed to the failure mode collapsed pylon. in the us market and in canada, labeling requires a condition based service at three years. in the rest of the world, a mandatory two year service interval is specified. only the devices in distribution in the united states and canada are affected by this action.
  • Action
    On September 14, 2017 a letter was sent to all their consignees via 2nd day signature receipt required to customers instructing them to contact their patients and send in their devices for service within the first 2.3 years of use. The pylon clamp will be replaced at no charge. The pylon will also be inspected and replaced if necessary. The customer will be requested to complete a reply form indicating they have received the notice and intend to contact their patients to arrange for the requested service. Customer Service: (800) 328-3458  Option 1 Loaner Service: (800) 328-3458  Option 3, then Option 1

Device

OTTO BOCK Kenevo knee joints
  • Model / Serial
    Serial Numbers:  201520028, 201520027, 20150026, and 201530040.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AK, AR, AZ, CA, CT, DC, GA, IL, IN, KY, LA, MD, MI, MN, NC, ND, NJ, MN, NY, OH, OK, OR, PA, PR, TX, VA, and WA AU, BE, DE, FR, GB, IT, KW, LU, NL, NO, AT, SA, SE, CH, ES, ZA, and HU
  • Product Description
    OTTO BOCK Kenevo knee joints Model 3C60=ST
  • Manufacturer
    Otto Bock Healthcare Product

Manufacturer

Otto Bock Healthcare Product