Recall Z-2294-2019— TiSport, Llc

Name: FDA recall Z-2294-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-11

Class II · Terminated

Class II FDA medical device recall by TiSport, Llc, initiated 2018-09-11, terminated 2022-07-29. It names 3 FDA 510(k) clearances: K072311, K023606, K990358. 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: The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards..

Recalling firm: TiSport, Llc
Classification: Class II
Status: Terminated
Initiated: 2018-09-11
Terminated: 2022-07-29
Firm location: Pasco, WA, United States

510(k) clearances named in this recall

3 on FDA's record

K072311 — TILITE AERO XTisport, LLC·cleared 2007-09-21
K023606 — TILITE YG AND TILITE YGSTisport·cleared 2002-11-19
K990358 — CROSS SPORT, RIGID WHEELCHAIRTisport·cleared 1999-02-26

K-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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.