FDAFDA · Alimentos y medicamentos·N.º oficial Z-2083-2014
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.
Publicado el 30 de julio de 2014 · Inicio del retiro: 3 de junio de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- DePuy Orthopaedics, Inc.
- Distribuidor
- 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.
- Lote
- 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,
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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