Z-0264-2022Class II

Permobil TiLite, Models: Aero Z, and ZRA

Name: Z-0264-2022 Permobil TiLite, Models: Aero Z, and ZRA
Creator: TiSport, Llc
Published: 2021-09-24
License: https://open.fda.gov/license/

TiSport, LLC / initiated 2021-09-24 / Open, Classified

FDA source

TiSport, Llc began a recall of Permobil TiLite, Models: Aero Z, and ZRA on 2021-09-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0264-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-24
Posted: 2021-11-18
Recalling firm: TiSport, LLC
Product: Permobil TiLite, Models: Aero Z, and ZRA
Product code: IOR Wheelchair, Mechanical
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.
FDA root cause: Component change control
Action: On 09/24/21, distribution of correction notices started, via mail, to distributors. Distributors were advised the following: For AERO Z wheelchairs, the transit tie downs should have an inward orientation with transit bracket in rear most position. The wheelchair provider was provided with clear and thorough work instructions on how to inspect and, when necessary, correctly configure the transit tie downs. Stop using TiLite ZRA with transit tie downs as a passenger seat in a motor vehicle. Remove transit tie downs on TiLite ZRA wheelchairs. The recalling firm, if requested, will supply at no cost to the provider or the end-user an Aero Z with transit tie downs as a replacement for the ZRA. Once transit tie downs for the ZRA have been redesigned, verified, and released to the market, the updated transit tie downs will be provided, and the return of the replacement Aero Z will be coordinated. On October 1st, 2021, an update will be provided on our progress regarding the redesigned transit tie downs for ZRA wheelchair models. Customers with questions or concerns are encouraged to email [email protected] or phone 800 736 0925, option 2. Distributors were advised that this market correction needs to be carried out at the consumer and end-user level. They were asked to immediately identify and contact their customer(s) with affected serial numbers. Distributor notification to customers may be more effective by including a copy of the end-user letter, which is attached with the distributor correction notice. If they are unable to contact the end-user or the transit tie downs/wheelchair are no longer available, please indicate this on the Serial Number Verification Form.
Quantity in commerce: 5373
Distribution: US Nationwide Distribution: MD, PA, VA, IN, NY, MO, AR, NE, NJ, WA, NM, IL, CA, OH, KY, LA, OK, WI, TX, NC, SD, MN, MA, OR; OUS (Foreign): AUSTRALIA, CANADA, FRANCE, GERMANY, IRELAND, ITALY, UNITED KINGDOM, URUGUAY, NEW ZEALAND, IRELAND, SWEDEN
Product codes and lots: Manufactured between January 19, 2017 and June 14, 2021 with the serial number range from M2005054 to 1231112011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0264-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0264-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-24	2021-11-18

Product code IOR

K990358Class ICross Sport, Rigid WheelchairTisport / cleared 1999-02-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)