Events

Recall of Twister(tm) Cube Back-Cane Short, a wheelchair back seat support strap, part number WPHS.

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

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
    25755
  • Event Risk Class
    Class 2
  • Event Number
    Z-0812-03
  • Event Initiated Date
    2003-02-25
  • Event Date Posted
    2003-05-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26436
  • 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
    Wheelchair, Mechanical - Product Code IOR
  • Reason
    Stitching in wheelchair seat back is defective and may not support user.
  • Action
    Firm notified dealers and sales representatives by certified letter on 2/25/03. Dealers were requested to phone the company for replacement options. Sales representatives were advised of the stitching failure via an 'urgent product recall' letter and instructed to immediately cease use and distribution, and further notify customers. Reps were asked to collect all recalled parts WPHS from consignees they have identified and return with response form.

Device

Twister(tm) Cube Back-Cane Short, a wheelchair back seat support strap, part number WPHS.
  • Model / Serial
    LOTS IA702, II327, IK454, IM236
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to dealers, independent sales representatives, and distributors around the US and worldwide.
  • Product Description
    Twister(tm) Cube Back-Cane Short, a wheelchair back seat support strap, part number WPHS.
  • Manufacturer
    Action Products Incorporated

Manufacturer

Action Products Incorporated
  • Manufacturer Address
    Action Products Incorporated, 22 N Mulberry Street, Hagerstown MD 21740
  • Source
    USFDA