Events

Recall of Leckey 4Point Pelvic Harness Belts

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Patterson Medical Holdings, Inc..

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
    52114
  • Event Risk Class
    Class 2
  • Event Number
    Z-2040-2009
  • Event Initiated Date
    2009-04-17
  • Event Date Posted
    2009-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82118
  • 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 chair - Product Code INN
  • Reason
    The plastic buckles on the hip belts of the 4-point pelvic harness may break.
  • Action
    Sammons Preston, the U.S. agent for James Leckey Design Ltd., issued recall letters dated 4/17/09 to all of their customers who purchased the Leckey 4-Point Pelvic Harness, used in the Leckey Contoured Advance Seat, Leckey Early Sitting System and the Leckey Squiggles Saddle Seat, informing them that the manufacturer, James Leckey Design Ltd., is recalling the harness because the pelvic belt buckle may not lock securely and/or break. A copy of the Urgent Field Safety Notice dated 1/28/09 issued by Leckey in the United Kingdom was included with the Sammons letter. The customers were advised to be vigilant and check the hip belts daily to ensure that the user is secure in their seating system until the replacement hip belt is received. The accounts were requested to contact Carla Dreher at 1-800-288-3693, ext. 8724 for instructions on how to receive a replacement hip belt.

Device

Leckey 4Point Pelvic Harness Belts
  • Model / Serial
    All belts supplied on the affected seating systems between September 2007 and December 2008
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Leckey 4-Point Pelvic Harness Belts, catalog 081326990; James Leckey Design Ltd., Kilwee Business Park, Upper Dunmurry Lane, Belfast, United Kingdom; Distributed by Patterson Medical; sold as replacement belts and as a component of the following adjustable mechanical chairs: || a) Leckey Contour Advance Seat, Size 1, catalog 081117209; || b) Leckey Contour Advance Seat, Size 2, catalog 081117217; || c) Leckey Squiggles Saddle Seat, catalog 081326941; || d) Leckey Early Sitting System, catalog 081395193
  • Manufacturer
    Patterson Medical Holdings, Inc.

Manufacturer

Patterson Medical Holdings, Inc.
  • Manufacturer Address
    Patterson Medical Holdings, Inc., 1000 Remington Blvd Ste 210, Bolingbrook IL 60440-5116
  • Source
    USFDA