Devices

Device Recall RECLAIM DISTAL TAPERED

  • 모델명 / 제조번호(시리얼번호)
    Product # 297500110 Lot # 126559; 126569, 181990, 181995, 224156, 231487, 240683, 260366, 260370, 272820, 272827, 272831 & 272836.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    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.
  • 제품 설명
    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

제조사

DePuy Orthopaedics, Inc.
  • 제조사 주소
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA

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데이터에 대해 더 자세히 알아보기 여기

Device Recall RECLAIM DISTAL TAPERED
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    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.
  • 제품 설명
    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.