TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device
FDA device recall Z-0942-2017 · posted 2017-01-03 · Terminated
Recall details
- Recalling firm
- Pride Mobility Products Corp
- Reason for recall
- The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle.
- Action taken
- 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
- Status
- Terminated
- Product code
- ITI
- Quantity affected
- 12,343 chairs
- Distribution
- Nationwide Distribution
- Date initiated
- 2016-12-01
- Date posted
- 2017-01-03
- Date terminated
- 2020-03-19
- Location
- Exeter, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNERGY ULTIMATE (K041346) | Pride Mobility Products Corp. | 2004-09-08 |