Z-0942-2017 Class II Terminated
FDA device recall Z-0942-2017 was initiated by Pride Mobility Products Corp on December 1, 2016 and is designated Class II. Reason for recall: The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle. The recall status is terminated (terminated March 19, 2020). Affected quantity: 12,343 chairs.
Recall Details
- Product Type
- Devices
- Report Date
- January 11, 2017
- Initiation Date
- December 1, 2016
- Termination Date
- March 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,343 chairs
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.
Distribution Pattern
Nationwide Distribution
Code Information
Numerous serial numbers affected (12,343 units)