Recall Z-2657-2014— Motion Concepts

Name: FDA recall Z-2657-2014
Creator: U.S. Food and Drug Administration
Published: 2014-08-28

Class II · Terminated

Class II FDA medical device recall by Motion Concepts, initiated 2014-08-28, terminated 2015-06-03. It names one FDA 510(k) clearance: K023426. Product: TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.. Reason: Motion Concepts identified that there is a possibility of knee support failure occurring through fatigue of two attachment bolts in the Vertical Position System (TRx Vertical Positioner)..

Recalling firm: Motion Concepts
Classification: Class II
Status: Terminated
Initiated: 2014-08-28
Terminated: 2015-06-03
Firm location: Concord, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K023426 — TRX VERTICAL POSITIONERMotion Concepts·cleared 2002-11-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.

Reason for recall

Motion Concepts identified that there is a possibility of knee support failure occurring through fatigue of two attachment bolts in the Vertical Position System (TRx Vertical Positioner).

Data sourced from openFDA. This site is unofficial and independent of the FDA.