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Terminated

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

FDA Recall Z-0942-2017 · Posted 2017-01-03

Recalling FirmPride Mobility Products Corp
Recall StatusTerminated
Product CodeITI
Date Initiated2016-12-01
Date Terminated2020-03-19
Product Quantity12,343 chairs

Reason for Recall

The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle.

Firm 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.

Root Cause

Use error

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041346SYNERGY ULTIMATEPride Mobility Products Corp. · 2004-09-08

Official Source

View FDA Recall →

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

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