FDA recall Z-2294-2019

TiSport, Llc · Class II · device

Product

TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs). Product Usage: The affected component is part of a manual wheelchair to provide mobility to physically impaired individuals. The affected component is used to prevent the wheelchair from tipping backwards.

Reason for recall

The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards.

Distribution

Distribution was nationwide, including Puerto Rico. There was also government distribution but no military distribution. Foreign distribution was made to Canada, Australia, Brazil, China, Italy, Saudi Arabia, Switzerland, United Kingdom, and Uruguay.

Key facts

Status
Terminated
Initiation date
2018-09-11
Report date
2019-08-28
Termination date
2022-07-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pasco, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2294-2019