Devices

Device Recall RECLAIM DISTAL TAPERED

  • Modèle / numéro de série
    Product # 297500110 Lot # 126559; 126569, 181990, 181995, 224156, 231487, 240683, 260366, 260370, 272820, 272827, 272831 & 272836.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to AUSTRALIA, AUSTRIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IBERIA, IRELAND, ISRAEL, ITALY, NEW ZEALAND, NORWAY, POLAND, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND & UK.
  • Description du dispositif
    RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
  • Manufacturer
    DePuy Orthopaedics, Inc.
  • 1 Event

Fabricant

DePuy Orthopaedics, Inc.
  • Adresse du fabricant
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA

2 dispositifs médicaux avec un nom similaire

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Device Recall RECLAIM DISTAL TAPERED
  • Modèle / numéro de série
    Product # 197714190; Lot # 107342, 107343, 107346, 107347, 138357, 138358, 138359, 138360, 138361, 138362, 138363, 163354, 163356, 163357, 190780, 190783, 190784, 211757, 211758, 225886, 225887, 228150, 228153, 231204, 235931, 235932, 235935, 246196, 246197, 251519, 251520, 254838, 254839, 264816, 264817, 282507, 282509, 282511, 282512, 288712, 288713, 288714, 288715, 288716 & 288717.  Product # 197715190; Lot # 107603, 107605, 107607, 107610, 107612, 138364, 138365, 138366, 138367, 138368, 138369, 138370, 138373, 138374, 163358, 211759, 211760, 211761, 225888, 225889, 228160, 228162, 228164, 228165, 228166, 235939, 235941, 239345, 254840, 254842, 260398, 260401, 264818, 264819, 282513, 282514, 282516, 288718, 288719, 288720, 288721, 288722, 288723 & 288725.  Product # 197716190; Lot # 136503, 136515, 136517, 136518, 136519, 136521, 136522, 136524, 136525, 136535, 190767, 190769, 190772, 190775, 190776, 196006, 196007, 196008, 196009, 226259, 226260, 226261, 228211, 228212, 228214, 231210, 235942, 235944, 239348, 246198, 246199, 246200, 260404, 260406, 264820, 264821, 264822, 282517, 282518, 282519, 288727, 288729, 288731, 288734 & 288736.  Product # 197716240; Lot # 107616, 107618, 107620, 107623, 150282, 150286, 150291, 150292, 151020, 151022, 151031, 151032, 151051, 196002, 196004, 196005, 211768, 211769, 226262, 226263, 231181, 231182, 231183, 231184, 231186, 231187, 231189, 239350, 246201, 246202, 260407, 260408, 264823, 264824, 282520, 282521, 282522 & 282524.  Product # 197717190; Lot # 107635, 107639, 107641, 107642, 107646, 150312, 150313, 150314, 150315, 150317, 150318, 151060, 151061, 151065, 151066, 151068, 152323, 152324, 152325, 152328, 152330, 152332, 152333, 231205, 231211, 239352, 239355, 239359, 246203, 246204, 260409, 260410, 264825, 264826, 264828, 316404, 316405, 316406, 316408, 372515, 415503, 422253, 428484, 451588, 452551, 452552, 453414, 453415, 454332, 455528, 493028, 493029, 493030 & 499967.  Product # 197717240; Lot # 110419, 110423, 110424, 110425, 110426, 152336, 152337, 152338, 152740, 152741, 152745, 152746, 152750, 152752, 152755, 211770, 211771, 211772, 226264, 231196, 231197, 231198, 231199, 231201, 239360, 239361, 239362, 245262, 245265, 260411, 260415, 264829 & 264830.  Product # 197718190; Lot #, 152758, 152763, 152768, 152769, 153106, 153107, 153108, 153109, 153110, 153111, 153112, 153113, 153114, 153115, 153116, 153117, 153118, 153119, 228219, 228222, 228223, 231212, 235945, 240639, 240641, 240642, 246238, 246239 , 251521, 251522, 260416, 260420, 265279, 265281, 265282, 339777, 339785, 339798, 339801, 339803, 339817, 469297, 493032, 499969, 503929 & 523803.  Product # 197718240; Lot # 153612, 153615, 153616, 153617, 153619, 153620, 153621, 153623, 153624, 153625, 153627, 153628, 153629, 153630, 154207, 154208, 154209, 231207, 231208, 231209, 231213, 231214, 231215, 246241, 246242, 260425, 260427, 265283, 265284, 65285 & FF9RSA.  Product # 197718290; Lot # 343075, 352965, 352966, 352967, 371864, 371868, 371884, 371888 & 371889.  Product # 197719190; Lot # 154215, 154216, 154218, 154219, 154223, 154224, 154227, 154228, 154231, 154232, 154235, 154236, 154903, 154905, 154910, 154911, 154914, 154915, 154917, 154918, 154919, 154920, 154921, 154922, 228216, 246243, 246244, 260430, 260432, 265286, 265288, 265289, 265290, 339819, 339821, 339823, 339828, 339832, 339833, 453416, 454333, 454334, 457064, 457067, 457068 & 503927.  Product # 197719240; Lot # 154923, 154924, 154925, 155258, 155259, 155261, 155262, 155263, 155264, 155265, 155266, 155267, 155268, 155269, 155270, 155271, 155272, 155273, 155274, 155665, 155667, 155668, 260435, 260438, 265292, 265293, 339834, 339835, 339836, 339837, 339853 & 339854.  Product # 197719290; Lot # 343076, 352968, 352969, 371890, 371891, 371892 & 371893.  Product # 197720190; Lot # 155671, 155674, 155675, 155679, 155680 , 155682, 155684, 155689, 155691, 155697, 155698, 155703, 155704, 157780, 157782, 157783, 157786, 157787, 157791, 157792, 157793, 157796, 157800, 240654, 246246, 246247, 246248, 260442, 260448, 265294, 265295, 265296, 265297, 457655, 460826 , 475331, 520983 & 523804.  Product # 197720240; Lot # 110427, 110428, 110429, 110430, 110431, 157811, 157812, 157826, 157827, 157833, 158335, 158338, 158339, 158346, 158347, 158353, 158354, 158361, 158362, 158363, 231216, 231217, 231218, 231219, 236967, 236969, 240655, 240656, 251523, 251524, 254845 &, 254848.  Product # 197720290 Lot # 343077, 352970, 371899, 371900, 371901, 371902, 371903, 371905 & 371906.  Product # 197721190; Lot # 158364, 158365, 158366, 158368, 158369, 158859, 158860, 158862, 158863, 158865, 158866, 158870, 158871, 158874, 158875, 158879, 158881, 158884, 158885, 235947, 235948, 240657, 240658, 251527, 251528, 260452, 260453, 260456, 265298, 265299, 415504, 446635, 497258 & FG2XWA.  Product # 197721240; Lot # 159674, 159676, 159682, 159683, 159686, 159687, 159689, 159692, 159697, 159699, 159702, 159704, 159707, 159708, 159713 , 226266, 231220, 231221, 231222, 231223, 235950, 240659, 251530, 251531, 260458, 260459, 260460, 265300 , 265301 & E72JPA. Product # 197721290; Lot # 343078, 352971, 352972, 352973, 352974, 371907, 371908, 371909, 371910 & 371911.  Product # 197722190; Lot # 107658, 107660, 107662, 107666, 107670, 160042, 160043, 160045, 160046, 160049, 160051, 160055, 160056, 160059, 160060, 160062, 160063, 160065, 226267, 226269, 228167, 228168, 228170, 228172, 228175, 240660, 240661, 240662, 251532, 251534, 254851, 254853, 265660, 265661, 339857, 339861, 339864, 339868, 339875, 339880 & E72KNA.  Product # 197722240; Lot # 108360, 108361, 108362, 160067, 160069, 160070, 183484, 190402, 190403, 190407, 190408, 190409, 192784, 192792, 192795, 210716, 210718, 210719, 226270, 226271, 226272, 231224, 231225, 231226, 238694, 238695, 238696, 246249, 246250, 254854, 254855, 260462 & 260463.  Product # 197723190; Lot # 108363, 136546 , 136548, 136550, 136551, 136552, 136553, 160701, 160702, 160703, 160704, 160705, 160706, 195997, 195998, 195999, 230474, 230475, 230477, 230478, 230480, 230481, 230482, 231227, 235951, 240663, 240664, 240666, 251535, 251536, 260466, 260469, 265662, 265663, 469298 & 499968.  Product # 197723240; Lot # 108368, 108369, 108370, 183408, 183409, 183413, 183415, 190412, 190418, 190419, 190420, 190423, 190764, 192804, 192805, 192809, 192810, 210710, 226273, 226276, 226277, 231228, 231229, 231230, 235953, 240673, 240674, 251537, 251538, 254856 & 254857.  Product # 197723290; Lot # 318199, 318201, 318204, 318206, 318208, 318210, 323905, 323906, 323907, 323913 & 323918.  Product # 197724190; Lot # 108371, 108372, 108373, 108374, 108375, 108376, 160708, 160711, 160712, 160714, 160715, 160717, 160718, 160719, 160720, 161365, 161366, 161371, 226278, 226279, 228177, 228178, 228180, 228181, 228183, 235955, 240675, 240676, 251539, 251540, 260470, 260472, 265665 & 265666.  Product # 197724240; Lot # 108867, 108871, 108876, 108877, 108880, 108884, 183417, 192257, 192259, 192261, 192264, 201140, 202531, 202532, 202533, 202534, 202535, 226285, 226286, 226287, 231231, 231232, 231233, 231234, 235956, 240677, 240678, 246251, 246252, 254858, 254859, 260475, 260477, 260479 & E81LPB.  Product # 197725190; Lot # 108888, 108889, 108893, 108895, 108896, 161376, 161469, 161471, 161475, 161476, 161477, 161478, 161481, 161482, 161483, 161484, 161488, 210704, 226290, 226292, 226293, 231235, 231236, 231237, 235958, 240679, 240680, 240681, 251544, 251545, 260481, 260486.  Product # 197725240; Lot # 108900, 108905, 108907, 108911, 108912, 191549, 191551, 192267, 192268, 192771, 192775, 192778, 210672, 210686, 210687, 210693, 210694, 210700, 226294, 226295, 231238, 231239, 231240, 235959, 245271, 251547, 251548, 251549, 254803, 254805, 254810 & 254811.  Product # 197725290; Lot # 343079, 352975, 352976, 352977, 430904, 430905 & 430906.  Product # 197726190; Lot # 108916, 108920, 108923, 108926, 108930, 161924, 161925, 161926, 161928, 161929, 161930, 161931, 161933, 161935, 161937, 161938, 161939, 226297, 226301, 226302, 226304, 231241, 231242, 231243, 231244, 245273, 251551, 251552, 251553, 260490, 260496, 265667 & 265668.  Product # 197726240; Lot # 110393, 110395, 110399, 110400, 110402, 191533, 191535, 191537, 191539, 192247, 192251, 192253, 192255, 226305, 226306, 226307, 226308, 226309, 229204, 229205, 229207, 229208, 229209, 231245, 231246, 246253, 246254, 254860, 254861, 265672 & 265675.  Product # 197727190; Lot # 110404, 110405, 110406, 110407, 110409, 161944, 161947, 161948, 162555, 162557, 162558, 162560, 162561, 162565, 162566, 162572, 162573, 226310, 226311, 231247, 231248, 231249, 231250, 235960, 245274, 254862, 254863, 254864, 260503, 260504, 260508, 277152, 277153, 277155, 277158, 277161 & 277163.  Product # 197727240; Lot # 110411, 110412, 110414, 110414A, 110416, 110418, 191503, 191509, 191512, 191514, 201136, 201137, 226312, 226313, 226314, 226315, 226316, 231251, 231252, 231253, 231254, 245277, 254865, 260513, 260515, 260516, 352978, 352979, 430907, 430908 & 430909.  Product # 197729190; Lot # 343081, 353019, 353020, 353022 & 353023.  Product # 197729240; Lot # 343082, 353091, 353092, 353093, 353095 & 353099.  Product # 197729290; Lot # 343083, 352980, 352981, 352982, 352983 & 352984.  Product # 197731190; Lot # 343084, 353103, 353105, 353109, 353110, 353111 & 353113.  Product # 197731240; Lot # 343085, 353115, 353118, 353122, 353123 & 353126.  Product # 197731290; Lot # 331096.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to AUSTRALIA, AUSTRIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IBERIA, IRELAND, ISRAEL, ITALY, NEW ZEALAND, NORWAY, POLAND, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND & UK.
  • Description du dispositif
    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
  • Manufacturer
    DePuy Orthopaedics, Inc.
Device Recall RECLAIM DISTAL TAPERED
  • Modèle / numéro de série
    Product # 197614140; Lot # 107310, 107311, 107313, 107314, 107315, 136244, 136247, 136251, 136252, 136256, 136257, 136262, 136268, 136271, 136276, 136286, 196221, 196222, 196225, 225871, 225872, 225873, 228185, 228187, 228188, 235886, 235887, 240634, 240635, 246147, 246179, 254812, 254814, 260373, 260374, 264629, 264630, 281910, 281911, 281912, 281915, 288356, 288359, 288361, 288363, 442821, 451586, 452549, 453409, 455523, 455524, 456513, 456514, 456515, 457650 & 457651.  Product # 197614190; Lot # 290958, 290959, 290960, 310940, 310941, 310942, 310947, 310948, 327468, 327469, 327475, 327477, 327478, 327480, 365792, 365793, 365794, 365795, 365796 & 365797. Product # 197615140; Lot # 107320, 107323, 107325, 107328, 107330, 107331, 136369, 136370, 136371, 136372, 136373, 136374, 136375, 136376, 136377, 136377A, 136378, 136380, 136381, 196227, 196228, 225874, 225875, 225876, 228196, 228197, 228198, 231202, 235888, 235890, 239254, 239255, 251499, 251500, 251502, 251504, 254817, 254818, 260375, 260377, 264633, 264638, 383749, 393633, 405087, 420828, 421141, 432535, 442823, 451846, 457652, 465564, 465565, 480737, 482786, 491057, 497256, 503931, 518456, 523799 & 526931.  Product # 197615190; Lot # 290964, 290966, 290967, 290969, 311800, 311802, 311804, 311806, 311808, 323743, 323744, 323746, 323748, 323750, 323754, 387702, 387703, 387704, 387705 & 387706.  Product # 197616140; Lot # 136419, 136420, 136454, 136455, 136456, 136457, 136459, 136460, 136467, 136478, 136480, 136481, 225877, 225878, 225879, 225880, 225881, 228126, 228127, 228128, 228129, 228130, 239256, 239257, 240636, 246148, 246149, 246180, 254822, 254825, 260378, 260379, 264639, 264640, 264641, 281918, 281922, 281923, 281924, 288366, 288367, 288368, 288370, 288374, 405088, 405089, 415495, 418748, 421512, 422731, 461416, 461417, 461418, 461419, 461420, 461421, 466522, 466523, 466524, 466525, 472003, 475333, 482787, 493055, 499964, 503926, 516019, 518462, 520979, 523800, 526933 & FH1PH1.  Product # 197616190; Lot # 290971, 290972, 290975, 290977, 314437, 314438, 314439, 314451, 314454, 331071, 331072, 331073, 331074, 331076, 331077, 331081, 331082, 331085, 331086, 331087, 331088 & 331089.  Product # 197617140; Lot # 107333, 107334, 107336, 107338, 107339, 107340, 136561, 136564, 136565, 136566, 136568, 136569, 136574, 136575, 162577, 162578, 162580, 162581, 162582, 163061, 163062, 163063, 228199, 228200, 228202, 235892, 235893, 239258, 239259, 239261, 246151, 246152, 246181, 251506, 251507, 251509, 260380, 260381, 260382, 264642, 264643, 281926, 281927, 316391, 316394, 316396, 316399, 339767, 339768, 339769, 339770, 339771, 339773, 339774, 393634, 400314, 405090, 415496, 415497, 421921, 432022, 432537, 438468, 442824, 451587, 452550, 453410, 455526, 457653, 465566, 469296, 472012, 480807, 482788, 497257, 503930, 520980, 520981, 520982 & 523801.  Product # 197617190; Lot # 310403, 310949, 310950, 310951, 310952, 310953, 365800, 365806, 365808, 365810, 365811, 388879, 388883, 388885, 388888, 388891 & 388895.  Product # 197618140; Lot # 136576, 136577, 136578, 136579, 136580, 136581, 136583, 136584, 136585, 136587, 136588, 136589, 163065, 163066, 163068, 163069, 163070, 163071, 235894, 235927, 239264, 239297, 239301, 246154, 246182, 251511, 251512, 254826, 254827, 281928, 281929, 281931, 281932, 288706, 288707, 288708, 288709, 288710, 288711, 383750, 405091, 405092, 415498, 422252, 422733, 432540, 438059, 445826, 451847, 453411, 457654, 462108, 465567, 475332, 480808, 493056, 499966, 516009, 518464, 523802, 526934, FF8M1A, FF8M2A & FF8M3A.  Product # 197618190; Lot # 294652, 294654, 294658, 294659, 323871, 323873, 323874, 323875, 323876, 323877, 323878, 323880, 323882, 323884, 323886, 323888, 323890, 365971, 365979, 365983, 365988 & 365991. Product # 197619140; Lot # 138296, 138299, 138300, 138302, 138303, 138305, 138307, 138309, 138310, 138313, 138316, 163073, 163074, 163075, 163076, 163077, 163350, 163353, 228205, 228207, 235928, 235930, 239303, 239304, 239306, 246156, 246183, 251513, 251516, 254829, 254830, 260383, 260384, 264644, 264645, 281934, 281935, 281936, 281938, 281939, 288375, 288377, 288380, 288382, 288384, 445827, 451848, 453412, 453413, 455527, 482789, 482790, 493057, 494062 & FF9NAA.  Product # 197619190; Lot # 290981, 290982, 290985, 290986, 290990, 290991, 290992, 290995, 290997, 290999, 291000, 311325, 323893, 323895, 323897, 323899, 323901, 323902, 323904, 327356, 327358, 327359, 327360, 327361, 327362, 327363 & 327364.  Product # 197620140; Lot # 138319, 138321, 138322, 138323, 138331, 196229, 196231, 196232, 225882, 225883, 228131, 228132, 228134, 228135, 228140, 239320, 239322, 239328, 246187, 246190, 260386, 260394, 264812, 264813, 281940, 281942, 281943, 281945, 281946, 288387, 288390, 288392, 288394, 288401, 493058, 494063, FF9NLA & FF9NMA.  Product # 197620190; Lot # 274964, 274965, 274966, 274976, 274977, 274978, 274979, 275004, 275006, 275007, 275009, 367589, 367590, 367591, 367592 & 367593.  Product # 197621140; Lot # 138343, 138346, 138347, 138349, 138350, 138351, 138352, 138353, 138354, 138355, 138356, 196240, 196242, 225884, 225885, 228143, 228145, 228146, 228147, 228148, 239335, 239337, 239340, 240637, 251517, 251518, 254831, 254836, 264814, 264815, 281954, 281955, 281956, 281957, 281958, 288419, 288420, 288423, 288426, 288427, 288428 & FG211A.  Product # 197621190; Lot # 275013, 275014, 275015, 275018, 275019, 275021, 275022, 368544, 368548, 368549, 368550, 368551, 368632, 399737, 399738, 399739, 399740 & 399741.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to AUSTRALIA, AUSTRIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IBERIA, IRELAND, ISRAEL, ITALY, NEW ZEALAND, NORWAY, POLAND, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND & UK.
  • Description du dispositif
    RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
  • Manufacturer
    DePuy Orthopaedics, Inc.