Events

Recall of Device Recall wheeled adult and junior walkers

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
    58556
  • Event Risk Class
    Class 2
  • Event Number
    Z-3280-2011
  • Event Initiated Date
    2011-03-02
  • Event Date Posted
    2011-09-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99590
  • 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
    The firm is conducting a recall/correction of their adult and junior wheeled walkers due to a component defect. the firm determined that the caster bolt on the wheeled extension was too short to adequately maintain the nylex fastener. consequently, over time, this condition incurs the potential for the caster to loosen and detach, causing the wheels to fall off the walker. this scenario would res.
  • Action
    The firm, Invacare Corporation notified their customers of this recall/corrective action via an 'URGENT RECALL INFORMATION' letter dated April 7, 2011. The letter was sent to the customers by registered mail or Federal Express. The letter informs the customer(s) of the component defect involved and the inherent possibility that over time, a walker wheel(s) could fall off resulting in instability of the product and potential for serious injury to the user of the device. The letter provides a list of the affected units sold to each facility on an enclosed tracking sheet. It also asks that the customer: 1) Examine their stock for the presence of any of the affected walkers and to quarantine any such products found; 2) Complete an attached recall response form indicating the customers receipt and understanding of the instructions provided in the letter and to fax the completed form to the telephone number listed on the bottom of the form. The letter goes on to state that once the faxed back form is received by Invacare, the company will send the customer replacement wheels kits for all affected walkers purchased; 3) the customer is asked upon receipt of the replacement wheel kits to replace the wheels of any units still in stock and discard all of the old wheel parts removed; 4) Lastly, the customer is asked to contact their sub-account customers and notify them of the recall. If the customer have any questions concerning the instructions, call the recall support line at 1-866-567-7899.

Device

Device Recall wheeled adult and junior walkers
  • Model / Serial
    All 6240-5F and 6240-JR5F wheeled walkers distributed by the firm between 12/15/2010 and 3/4/2011, are subject to recall/correction.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, including Puerto Rico and countries of Canada, Columbia, and Israel.
  • Product Description
    Dual Blue-Release Adult Walkers - Wheeled, and Blue Release Junior Walkers with 5 inch Fixed Wheels, Model Numbers: 6240-5F and 6240-JR5F. The recalled product is packaged four (4) units per shipping box. || Product Usage: The walkers are intended for people who need additional support to maintain balance or stability while walking.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-4190
  • Manufacturer Parent Company (2017)
    Invacare Corporation
  • Source
    USFDA