FDA Medical Device Recalls (openFDA)
TiSport, Llc: Permobil TiLite, Models: Aero Z, and ZRA
- Recall number
- Z-0264-2022
- Recalling firm
- TiSport, Llc
- Product
- Permobil TiLite, Models: Aero Z, and ZRA
- Status
- Open, Classified
- Initiated
- 2021-09-24
- Posted
- not on file
- Terminated
- not on file
- 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.
- 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 tilite_quality@permobil.com 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
- 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
- Lot, serial or model codes
- Manufactured between January 19, 2017 and June 14, 2021 with the serial number range from M2005054 to 1231112011
- 510(k) numbers
- ["K990358"]
- PMA numbers
- not on file
- Product code
- IOR
- Firm FEI
- 3002653226
- Firm city
- Pasco
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28