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Terminated

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.

FDA Recall Z-2294-2019 · Posted None

Recalling FirmTiSport, Llc
Recall StatusTerminated
Product CodeIOR
Date Initiated2018-09-11
Date Terminated2022-07-29
Product Quantity1,452 wheelchairs

Reason for Recall

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

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072311TILITE AERO XTisport, LLC · 2007-09-21K023606TILITE YG AND TILITE YGSTisport · 2002-11-19K990358CROSS SPORT, RIGID WHEELCHAIRTisport · 1999-02-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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