Recall Z-2294-2019 ยท IOR Wheelchair, Mechanical
TiSport, Llc
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.
| Date | Sep 11, 2018 |
| Status | Terminated |
| Reason | The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards. |
| Root cause | Component design/selection |
| Action | The recalling firm issued distributor letters dated 9/7/2018 via certified mail beginning on 9/11/2018. The letter identified the affected product, problem and actions to be taken. |
| Quantity | 1,452 wheelchairs |
| 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. |
| FDA record | Open on fda.gov |