TiSport, Llc: 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.

Recall number

Z-3161-2011

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.

Status

Terminated

Initiated

2011-07-05

Posted

2011-09-07

Terminated

2012-07-27

Reason

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

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 ProdCorrection@tilite.com. Customers can call Technical Support at 800-545-2266, ext. 239 with any questions about recall.

Quantity

1,037 units

Distribution

Worldwide Distribution

Lot, serial or model codes

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56250, 56254, 56260, 56266, 56272, 56276, 56278, 56284, 56287, 56298, 56305, 56311, 56327, 56328, 56329, 56332, 56341, 56344, 56348, 56349, 56354, 56356, 56359, 56360, 56367, 56370, 56372, 56375, 56377, 56394, 56427, 56447, 56462, 56463, 56467, 56468, 56470, 56476, 56482, 56485, 56487, 56497, 56498, 56502, 56507, 56510, 56512, 56514, 56515, 56522, 56523, 56529, 56531, 56534, 56540, 56542, 56545, 56557, 56560, 56563, 56570, 56573, 56575, 56577, 56578, 56581, 56584, 56588, 56592, 56600, 56601, 56611, 56618, 56619, 56623, 56624, 56628, 56631, 56639, 56640, 56643, 56646, 56650, 56652, 56653, 56654, 56659, 56661, 56663, 56675, 56679, 56684, 56686, 56687, 56694, 56705, 56711, 56712, 56716, 56717, 56718, 56719, 56729, 56734, 56736, 56743, 56744, 56748, 56749, 56752, 56755, 56768, 56771, 56773, 56784, 56791, 56794, 56795, 56805, 56811, 56813, 56817, 56823, 56834, 56838, 56845, 56857, 56865, 56880, 11902420, 11902447, 11902458, 11902461, 11902463, 11902464, 11902473, 11902475, 11902479, 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11903993, 11903999, 11904018, 11904019, 11904410, 11904413, 11904416, 11904418, 11904422, 11904426, 11904430, 11904431, 11904434, 11904445, 11904603, 11904605, 11904609, 11904611, 11904618, 11904626, 11904689, 11904690, 11904697, 11904705, 11904757, 11904896, and 53309A.

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

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

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