Events

Recall of Device Recall TRUBalance3 Power Positioning System

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

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
    75881
  • Event Risk Class
    Class 2
  • Event Number
    Z-0942-2017
  • Event Initiated Date
    2016-12-01
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151534
  • 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, powered - Product Code ITI
  • Reason
    The interface between the tb3 back and tilt base can separate when tilted beyond the specified angle.
  • Action
    Pride Mobility Products Corp. mailed a letter to affected customers to inform them of the issue. Systems were not required to be returned. Customers were informed that a TB3 Seat Depth Adjustment Reinformcement Kit which contains (2) reinforcement plates and associated hardware to strengthen the interface will be installed to address the issue. Direct accounts were asked to contact patients to inform them of the product correction. Customers were also requested to complete and return Pride's completion card once the correction has been made. Pride will issue a $65.00 credit once the completion card is received. Customers with questions were instructed to call Pride's Upgrade Department at 866-222-6212. For questions regarding this recall call 800-800-8586.

Device

Device Recall TRUBalance3 Power Positioning System
  • Model / Serial
    Numerous serial numbers affected (12,343 units)
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). || Mobility Medical Device
  • Manufacturer
    Pride Mobility Products Corp

Manufacturer

Pride Mobility Products Corp
  • Manufacturer Address
    Pride Mobility Products Corp, 182 Susquehanna Ave, Exeter PA 18643-2653
  • Manufacturer Parent Company (2017)
    Pride Mobility Products Corp
  • Source
    USFDA