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U.S. Department of Health and Human Services

Class 2 Device Recall TRx Vertical Positioner

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  Class 2 Device Recall TRx Vertical Positioner see related information
Date Initiated by Firm August 28, 2014
Date Posted September 17, 2014
Recall Status1 Terminated 3 on June 03, 2015
Recall Number Z-2657-2014
Recall Event ID 69113
510(K)Number K023426  
Product Classification Wheelchair, powered - Product Code ITI
Product TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.
Code Information 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, U002519, U002716, U002922, U003577, U004011, U004018, U004073, U004079, U004145, U004214, U004400, U004404, U004472, U004485, U006042, U006234, U006235, U006260, U006295, U006296, U006353, U006378, U007126, U007138, U007163, U007239, U007245, U007279, U007288, U007407, U008556, U008631, U008698, U008840, U008896, U009548, U009569, U009579, U009707, U009718.
Recalling Firm/
Manufacturer		 Motion Concepts
84 Citation Drive
Units 1-7
Concord Canada
Manufacturer 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).
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce US: 59 units
Distribution US Distribution in states of: AR, CA, CT, DE, IA, ID, IL, IN, MI, MD, MO, NE, NY, OH, PA, TN, TX, and WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ITI and Original Applicant = MOTION CONCEPTS
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