FDA Medical Device Recalls (openFDA)
Pride Mobility Products Corp: TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device
- Recall number
- Z-0942-2017
- Recalling firm
- Pride Mobility Products Corp
- Product
- TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device
- Status
- Terminated
- Initiated
- 2016-12-01
- Posted
- 2017-01-03
- Terminated
- 2020-03-19
- Reason
- The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle.
- 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
- 12,343 chairs
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Numerous serial numbers affected (12,343 units)
- 510(k) numbers
- ["K041346"]
- PMA numbers
- not on file
- Product code
- ITI
- Firm FEI
- 3005068474
- Firm city
- Exeter
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28