Z-3161-2011

TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite. The TiLite...

Name: Z-3161-2011 TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite. The TiLite...
Creator: TiSport, Llc
Published: 2011-07-05
License: https://open.fda.gov/license/

TiSport, LLC / initiated 2011-07-05 / Terminated / root cause: design

FDA source

TiSport, Llc began a recall of TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite. The TiLite ZR had a model catalog number of Z2FS1. The TiLite... on 2011-07-05. The reason FDA records is "The Pivot Stud Bolt comprising part of the backrest assembly of TiLite ZR Series 2 and ZRA Series 2 mechanical wheelchairs have shown a tendency to fail due to the head of the bolt being sheared off". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3161-2011
Status: Terminated
Initiated: 2011-07-05
Posted: 2011-09-07
Terminated: 2012-07-27
Recalling firm: TiSport, LLC
Product: TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite. The TiLite ZR had a model catalog number of Z2FS1. The TiLite ZRA has a model catalog number of Z2FS2. Provide mobility for physically impaired individuals.
Product code: IOR Wheelchair, Mechanical
Reason for recall: The Pivot Stud Bolt comprising part of the backrest assembly of TiLite ZR Series 2 and ZRA Series 2 mechanical wheelchairs have shown a tendency to fail due to the head of the bolt being sheared off.
Root cause tag: design
FDA root cause: Component design/selection
Action: An Urgent Medical Device Correction letter, Product Correction Kit , and the Installation Instructions were sent to domestic suppliers, international suppliers, Veterans Administration hospitals and international distributors by US Priority Mail and by FedEx three days service. The letter identified the affected product and the reason for the recall. Customers were instructed not to send the product to their end user until the correction was made or to identify their end user and notify the end user of the product correction. Replacement parts and instructions to correct the issue were enclosed with the letter. Customers were to destroy the removed parts once they had completed the correction. Customers were to also return the Medical Device Correct Report that was provided, by fax to 509-586-2413, or email to [email protected]. Customers can call Technical Support at 800-545-2266, ext. 239 with any questions about recall.
Quantity in commerce: 1,037 units
Distribution: Worldwide Distribution
Product codes and lots: 52359, 52493, 52501, 52532, 52552, 52586, 52588, 52590, 52632, 52689, 52700, 52718, 52722, 52737, 52740, 52754, 52760, 52778, 52785, 52792, 52804, 52820, 52824, 52830, 52833, 52836, 52842, 52847, 52856, 52862, 52874, 52875, 52879, 52899, 52911, 52918, 52924, 52926, 52951, 52958, 52978, 52979, 52982, 52994, 52997, 52998, 52999, 53008, 53014, 53034, 53038, 53048, 53051, 53070, 53089, 53094, 53111, 53120, 53123, 53146, 53163, 53174, 53186, 53206, 53209, 53219, 53222, 53236, 53242, 53250, 53254, 53256, 53258, 53259, 53260, 53265, 53267, 53270, 53274, 53276, 53285, 53286, 53287, 53290, 53294, 53295, 53299, 53303, 53316, 53335, 53343, 53396, 53427, 53436, 53444, 53454, 53458, 53465, 53467, 53487, 53490, 53493, 53497, 53504, 53509, 53511, 53520, 53525, 53526, 53533, 53534, 53542, 53543, 53547, 53551, 53555, 53564, 53569, 53570, 53580, 53585, 53591, 53610, 53635, 53641, 53660, 53674, 53695, 53711, 53713, 53723, 53727, 53734, 53740, 53756, 53780, 53790, 53794, 53800, 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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)