The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2657-2014·Announced 2014-09-24

Motion Concepts Recalls TRx Vertical Positioner Due to Knee Support Failure Risk

Motion Concepts is recalling 59 TRx Vertical Positioner units because knee supports may fail due to bolt fatigue.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device (wheelchair component) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Motion Concepts is recalling 59 units of the TRx Vertical Positioner, a wheelchair component classified as a Power Positioning System. The recall covers all units manufactured between June 2011 and May 2014. These devices were distributed in the United States across the states of Arkansas, California, Connecticut, Delaware, Iowa, Idaho, Illinois, Indiana, Michigan, Maryland, Missouri, Nebraska, New York, Ohio, Pennsylvania, Tennessee, Texas, and Washington.

The recall was initiated because Motion Concepts identified a possibility of knee support failure. This failure could occur through the fatigue of two attachment bolts in the Vertical Position System. The source text does not report any specific injuries or illnesses associated with this defect.

Consumers who possess a TRx Vertical Positioner should check their serial number against the list provided in the official recall notice to determine if their unit is affected. If the serial number matches, they should contact Motion Concepts for further instructions on how to address the potential safety issue.

The recalled product

Product
TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.
Manufacturer
Motion Concepts
Affected units
59

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • All units manufactured between June 2011 and May 2014: Serial Numbers 28583
  • 28597
  • 28604
  • 28607
  • 28629
  • 30334
  • 028380
  • U001050
  • U001083
  • U001544
  • U002020
  • U002326
  • U002386
  • U002403
  • U002411
  • U002489
  • U002502
  • U002505
  • U002509
  • U002510

Distribution

Distributed in 18 states:

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