Rappel de Device Recall TiLite ZR Series 2 and ZRA Series 2 Wheelchairs

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par TiSport, Llc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    59305
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3161-2011
  • Date de mise en oeuvre de l'événement
    2011-07-05
  • Date de publication de l'événement
    2011-09-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2012-07-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Mechanical Wheelchair - Product Code IOR
  • Cause
    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

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    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

Manufacturer

  • Adresse du fabricant
    TiSport, Llc, 2701 W Court St, Pasco WA 99301-3911
  • Société-mère du fabricant (2017)
  • Source
    USFDA