Recall Z-0942-2017— Pride Mobility Products Corp
Class II · Terminated
Class II FDA medical device recall by Pride Mobility Products Corp, initiated 2016-12-01, terminated 2020-03-19. It names one FDA 510(k) clearance: K041346. Product: TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device. Reason: The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle..
- Recalling firm
- Pride Mobility Products Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-01
- Terminated
- 2020-03-19
- Firm location
- Exeter, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device
Reason for recall
The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle.
Data sourced from openFDA. This site is unofficial and independent of the FDA.