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Terminated

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

FDA Recall Z-2657-2014 · Posted 2014-09-17

Recalling FirmMotion Concepts
Recall StatusTerminated
Product CodeITI
Date Initiated2014-08-28
Date Terminated2015-06-03
Product QuantityUS: 59 units

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).

Firm Action

URGENT RECALL NOTIFICATION Letters (dated 8/26/2014) were sent to customers on 8/26/14 via Federal Express. Motion Concepts is requesting that all customers that have purchased a Motion Concepts TRx Vertical Positioner system in between June 2011 - May 2014 to make arrangements for replacement of the knee support mount in accordance with the instructions enclosed in the letter. For questions, please contact us at 905-695-0134.

Root Cause

Device Design

Distribution Pattern

US Distribution in states of: AR, CA, CT, DE, IA, ID, IL, IN, MI, MD, MO, NE, NY, OH, PA, TN, TX, and WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023426TRX VERTICAL POSITIONERMotion Concepts · 2002-11-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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