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U.S. Department of Health and Human Services

Class 2 Device Recall TRUBalance3 Power Positioning System

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  Class 2 Device Recall TRUBalance3 Power Positioning System see related information
Date Initiated by Firm December 01, 2016
Date Posted January 03, 2017
Recall Status1 Terminated 3 on March 19, 2020
Recall Number Z-0942-2017
Recall Event ID 75881
510(K)Number K041346  
Product Classification Wheelchair, powered - Product Code ITI
Product TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1).
Mobility Medical Device
Code Information Numerous serial numbers affected (12,343 units)
Recalling Firm/
Manufacturer		 Pride Mobility Products Corp
182 Susquehanna Ave
Exeter PA 18643-2653
For Additional Information Contact
800-800-8586 Ext. 1381
Manufacturer Reason
for Recall		 The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle.
FDA Determined
Cause 2		 Use error
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.
Quantity in Commerce 12,343 chairs
Distribution Nationwide Distribution
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 = PRIDE MOBILITY PRODUCTS CORP.
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