Events

Recall of Knee Walker

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

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
    61550
  • Event Risk Class
    Class 2
  • Event Number
    Z-1704-2012
  • Event Initiated Date
    2012-04-06
  • Event Date Posted
    2012-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108408
  • 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
    Walker, mechanical - Product Code ITJ
  • Reason
    Adverse event data prompted testing of device, which revealed that the rod supporting the knee pad was not made to specifications. upon placing a load on the knee pad, the rod may break or bend causing the walker to collapse. as a result, the user may fall.
  • Action
    Invacare notified all consignees and distributors with a "Urgent: Recall Information" letter dated May 16, 2012. The product issue was described and recommended actions were provided to customers. Questions were directed to 1-888-257-7912.

Device

Knee Walker
  • Model / Serial
    Model number 65960
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of China.
  • Product Description
    Knee walker, one unit per box. Manufacturer Kenstone Metal (Kunshan) Co., LTD. The intended use is to provide additional mobility to individuals who have difficulty walking.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1 Invacare Way, Elyria OH 44035-4190
  • Manufacturer Parent Company (2017)
    Invacare Corporation
  • Source
    USFDA