Events

Recall of Device Recall TiLite ZR Series 2 and ZRA Series 2 Wheelchairs

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by TiSport, Llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59305
  • Event Risk Class
    Class 2
  • Event Number
    Z-3161-2011
  • Event Initiated Date
    2011-07-05
  • Event Date Posted
    2011-09-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102216
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Mechanical Wheelchair - Product Code IOR
  • 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.
  • 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.

Device

Device Recall TiLite ZR Series 2 and ZRA Series 2 Wheelchairs
  • Model / Serial
    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, 53801, 53812, 53821, 53823, 53826, 53829, 53835, 53836, 53838, 53839, 53841, 53860, 53862, 53864, 53865, 53870, 53874, 53882, 53883, 53885, 53891, 53907, 53909, 53911, 53914, 53917, 53935, 53955, 53956, 53972, 53978, 53988, 53996, 54006, 54012, 54023, 54035, 54062, 54079, 54083, 54088, 54097, 54102, 54114, 54118, 54124, 54127, 54129, 54139, 54159, 54168, 54178, 54187, 54190, 54195, 54196, 54202, 54206, 54211, 54218, 54221, 54223, 54237, 54242, 54243, 54244, 54278, 54281, 54282, 54297, 54317, 54321, 54325, 54339, 54341, 54349, 54354, 54356, 54365, 54381, 54383, 54385, 54386, 54390, 54395, 54413, 54415, 54416, 54422, 54445, 54448, 54450, 54451, 54464, 54468, 54470, 54478, 54493, 54500, 54520, 54534, 54539, 54540, 54541, 54552, 54558, 54559, 54566, 54567, 54569, 54576, 54579, 54584, 54595, 54607, 54608, 54613, 54625, 54643, 54648, 54661, 54662, 54674, 54684, 54685, 54690, 54694, 54695, 54711, 54717, 54720, 54723, 54727, 54728, 54733, 54735, 54737, 54742, 54744, 54746, 54749, 54752, 54760, 54763, 54764, 54765, 54772, 54778, 54781, 54783, 54793, 54795, 54801, 54807, 54812, 54813, 54815, 54816, 54820, 54825, 54829, 54831, 54832, 54836, 54838, 54839, 54846, 54848, 54853, 54862, 54865, 54870, 54875, 54876, 54877, 54884, 54885, 54890, 54893, 54902, 54917, 54929, 54930, 54932, 54940, 54942, 54953, 54955, 54971, 54973, 54978, 54979, 54980, 54981, 54982, 54985, 54986, 54987, 54989, 54990, 54993, 55003, 55009, 55027, 55031, 55032, 55034, 55037, 55040, 55041, 55046, 55048, 55059, 55060, 55079, 55083, 55091, 55105, 55106, 55109, 55123, 55125, 55149, 55171, 55180, 55183, 55200, 55203, 55209, 55211, 55222, 55236, 55237, 55244, 55251, 55255, 55256, 55258, 55261, 55262, 55268, 55274, 55288, 55292, 55298, 55314, 55317, 55319, 55322, 55324, 55325, 55326, 55327, 55331, 55336, 55337, 55342, 55346, 55352, 55358, 55359, 55370, 55383, 55385, 55389, 55402, 55406, 55407, 55414, 55415, 55418, 55421, 55429, 55435, 55437, 55439, 55442, 55447, 55453, 55455, 55459, 55461, 55467, 55472, 55476, 55477, 55488, 55492, 55496, 55499, 55506, 55512, 55514, 55527, 55529, 55531, 55535, 55550, 55555, 55567, 55581, 55582, 55583, 55585, 55587, 55591, 55593, 55595, 55607, 55620, 55632, 55644, 55646, 55666, 55668, 55670, 55673, 55676, 55682, 55690, 55694, 55697, 55706, 55710, 55712, 55713, 55714, 55717, 55718, 55725, 55729, 55730, 55732, 55735, 55742, 55753, 55754, 55756, 55758, 55763, 55767, 55768, 55777, 55787, 55822, 55828, 55847, 55861, 55876, 55886, 55891, 55894, 55896, 55904, 55908, 55912, 55913, 55914, 55917, 55918, 55919, 55921, 55928, 55929, 55931, 55932, 55936, 55937, 55938, 55939, 55940, 55941, 55944, 55946, 55948, 55949, 55950, 55951, 55954, 55959, 55960, 55964, 56015, 56017, 56019, 56020, 56021, 56026, 56030, 56038, 56064, 56069, 56070, 56079, 56080, 56084, 56089, 56092, 56093, 56095, 56101, 56104, 56106, 56112, 56117, 56119, 56124, 56125, 56127, 56128, 56132, 56133, 56134, 56135, 56145, 56149, 56151, 56159, 56161, 56170, 56190, 56193, 56196, 56198, 56200, 56208, 56213, 56226, 56236, 56239, 56243, 56244, 56245, 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, 11902484, 11902486, 11902487, 11902488, 11902491, 11902501, 11902510, 11902514, 11902516, 11902518, 11902519, 11902521, 11902527, 11902537, 11902538, 11902539, 11902544, 11902552, 11902553, 11902565, 11902567, 11902571, 11902572, 11902573, 11902576, 11902578, 11902579, 11902600, 11902603, 11902605, 11902614, 11902616, 11902621, 11902626, 11902627, 11902633, 11902643, 11902644, 11902645, 11902646, 11902647, 11902648, 11902654, 11902661, 11902663, 11902664, 11902665, 11902676, 11902680, 11902681, 11902688, 11902690, 11902693, 11902697, 11902700, 11902708, 11902710, 11902713, 11902723, 11902730, 11902735, 11902736, 11902737, 11902738, 11902739, 11902741, 11902743, 11902744, 11902749, 11902751, 11902756, 11902763, 11902767, 11902770, 11902778, 11902782, 11902783, 11902784, 11902793, 11902795, 11902796, 11902803, 11902804, 11902812, 11902814, 11902816, 11902819, 11902824, 11902830, 11902838, 11902839, 11902844, 11902845, 11902847, 11902868, 11902878, 11902880, 11902893, 11902897, 11902898, 11902905, 11902909, 11902911, 11902912, 11902915, 11902916, 11902920, 11902921, 11902939, 11902941, 11902946, 11902948, 11902949, 11902957, 11902961, 11902964, 11902967, 11902974, 11902975, 11902978, 11902980, 11902987, 11902988, 11902989, 11902990, 11903018, 11903021, 11903025, 11903028, 11903035, 11903037, 11903044, 11903045, 11903051, 11903065, 11903070, 11903071, 11903077, 11903083, 11903088, 11903096, 11903100, 11903102, 11903107, 11903111, 11903115, 11903121, 11903125, 11903131, 11903133, 11903136, 11903138, 11903141, 11903143, 11903146, 11903151, 11903165, 11903170, 11903180, 11903187, 11903197, 11903198, 11903200, 11903202, 11903203, 11903204, 11903212, 11903213, 11903215, 11903216, 11903219, 11903224, 11903228, 11903235, 11903239, 11903249, 11903250, 11903257, 11903258, 11903260, 11903269, 11903270, 11903276, 11903277, 11903279, 11903290, 11903308, 11903317, 11903320, 11903337, 11903353, 11903355, 11903356, 11903357, 11903368, 11903381, 11903382, 11903396, 11903404, 11903406, 11903417, 11903421, 11903427, 11903429, 11903432, 11903434, 11903435, 11903444, 11903450, 11903475, 11903478, 11903479, 11903483, 11903488, 11903491, 11903497, 11903506, 11903508, 11903510, 11903515, 11903516, 11903517, 11903518, 11903537, 11903551, 11903553, 11903557, 11903565, 11903572, 11903582, 11903591, 11903592, 11903598, 11903602, 11903607, 11903612, 11903621, 11903658, 11903663, 11903672, 11903676, 11903688, 11903708, 11903714, 11903715, 11903721, 11903722, 11903727, 11903728, 11903730, 11903732, 11903734, 11903751, 11903766, 11903776, 11903782, 11903788, 11903791, 11903794, 11903805, 11903807, 11903808, 11903815, 11903819, 11903825, 11903829, 11903830, 11903840, 11903845, 11903846, 11903847, 11903850, 11903861, 11903874, 11903876, 11903882, 11903889, 11903896, 11903900, 11903903, 11903905, 11903908, 11903911, 11903914, 11903918, 11903927, 11903932, 11903936, 11903940, 11903949, 11903959, 11903960, 11903961, 11903962, 11903968, 11903974, 11903980, 11903981, 11903982, 11903985, 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.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    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.
  • Manufacturer
    TiSport, Llc

Manufacturer

TiSport, Llc
  • Manufacturer Address
    TiSport, Llc, 2701 W Court St, Pasco WA 99301-3911
  • Manufacturer Parent Company (2017)
    Tisport Llc
  • Source
    USFDA