Recall Z-0264-2022— TiSport, Llc

Name: FDA recall Z-0264-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-24

Class II · Ongoing

Class II FDA medical device recall by TiSport, Llc, initiated 2021-09-24. It names one FDA 510(k) clearance: K990358. Product: Permobil TiLite, Models: Aero Z, and ZRA. Reason: Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may not be configured in the right orientation to perform as intended if involved in a motor vehicle accident. Some affected wheelchairs can no longer be used as a passenger seat until transit tie downs are replaced with redesigned transit tie downs, verified, and released to the market..

Recalling firm: TiSport, Llc
Classification: Class II
Status: Ongoing
Initiated: 2021-09-24
Firm location: Pasco, WA, United States

510(k) clearances named in this recall

1 on FDA's record

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

Permobil TiLite, Models: Aero Z, and ZRA

Reason for recall

Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may not be configured in the right orientation to perform as intended if involved in a motor vehicle accident. Some affected wheelchairs can no longer be used as a passenger seat until transit tie downs are replaced with redesigned transit tie downs, verified, and released to the market.

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