Events

Recall of Device Recall Cane

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
    63775
  • Event Risk Class
    Class 2
  • Event Number
    Z-0556-2013
  • Event Initiated Date
    2012-11-06
  • Event Date Posted
    2012-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114753
  • 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
    Cane, safety walk - Product Code KHY
  • Reason
    Following their receipt of several customer complaints, invacare recalled their height adjustable walking canes. the device was recalled from distribution based on reports indicating that there is a possibility that the button which holds the cane at the desired height, may suddenly and unexpectedly compress, causing the cane to collapse and cause possible injury to the user.
  • Action
    The firm, Invacare, sent an "URGENT MEDICAL DEVICE RECALL (Removal)" letter dated November 6, 2012 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to examine their existing stock using the enclosed detailed 'Product Tracking Sheet' and quarantine any affected canes; Acknowledge receipt and understanding of the urgent recall notice and indicate the number of canes remaining in inventory on the enclosed, 'Provider Response Card;'. Fax the completed Provider Response Card to Invacare Regulatory Affairs at: 1- 440-326-3544; disassemble each cane and discard both pieces in the trash; (Disassembly instructions are also provided); and lastly, contact Invacare Customer Service at 1-800-668-2337, Monday - Friday, 8 a.m. - 8 p.m. EST, to order replacement merchandise at no charge. If you have any questions concerning these instructions, contact Invacare Customer Service at 1-800-668-2337, Monday - Friday, 8 a.m. - 6 p.m. ET.

Device

Device Recall Cane
  • Model / Serial
    The Lot Codes subject to recall are: PW111201, PW120201, PW120101, PW120301, and PW120401
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN KS, KY, LA,MA, MD ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH,OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries of: Australia, Puerto Rico, and Taiwan Province of China.
  • Product Description
    Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping carton. || The cane is used as an aid in walking or ambulation.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-6248
  • Manufacturer Parent Company (2017)
    Invacare Corporation
  • Source
    USFDA