Z-0942-2017Class II

TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device

Name: Z-0942-2017 TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device
Creator: Pride Mobility Products Corp
Published: 2016-12-01
License: https://open.fda.gov/license/

Pride Mobility Products Corp / initiated 2016-12-01 / Terminated

FDA source

Pride Mobility Products Corp began a recall of TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device on 2016-12-01. FDA classified it as Class II and gives the reason as "The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0942-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-01
Posted: 2017-01-03
Terminated: 2020-03-19
Recalling firm: Pride Mobility Products Corp
Product: TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device
Product code: ITI Wheelchair, Powered
Reason for recall: The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle.
FDA root cause: 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
Product codes and lots: Numerous serial numbers affected (12,343 units)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0942-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0942-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-11	2017-01-03

Product code ITI

K041346Class IISynergy UltimatePride Mobility Products Corp. / cleared 2004-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)