Events

Recall of Device Recall Kuschall K Junior Manual wheelchair

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
    52445
  • Event Risk Class
    Class 2
  • Event Number
    Z-0421-2010
  • Event Initiated Date
    2009-06-15
  • Event Date Posted
    2009-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83032
  • 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
    Mechanical wheelchair - Product Code IOR
  • Reason
    The handle has been breaking at a calculated weight of 65 kg which may have serious consequences (broken bones) depending on the circumstances of the break (e.G., user on ramps, hills, etc.).
  • Action
    The firm contacted their customers by telephone and then sent a recall notification letter to each customer on 6/15/2009. Questions are directed to email: Recalls@Invacare.com or phone: 800-333-6900.

Device

Device Recall Kuschall K Junior Manual wheelchair
  • Model / Serial
    Model Numbers: 0806281234, 0806893858, 0806135534, 0806161578, 0806237627, 0806268153, 0806268154, 0806309590, 0806315524, 0806351557, 0806568768, 0806591793. 0806670117, 0806724855, 0806731287, 0806773921, 0807007811, 0807019897, 0807062866, 0807110193
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to the following states: CA, CO, MN, NJ, OR, PA, TX & VA and one to Canada.
  • Product Description
    Kuschall K Junior Manual wheelchair
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1 Invacare Way, PO Box 4028, Elyria OH 44035
  • Source
    USFDA