Events

Retiro De Equipo (Recall) de Device Recall DePuy ASR 100 Acetabular Implant, 56 mm

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Depuy Orthopaedics, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    55575
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2037-2010
  • Fecha de inicio del evento
    2010-03-05
  • Fecha de publicación del evento
    2010-07-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91234
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Prosthesis, hip, semi-constrained (metal uncemented acetabular component) - Product Code KWA
  • Causa
    Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
  • Acción
    DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.

Device

Device Recall DePuy ASR 100 Acetabular Implant, 56 mm
  • Modelo / Serial
    1144028, 1831565, 1852370, 1969280, 1969281, 1969282, 1979833, 1979834, 1986428, 2036221, 2049858, 2049859, 2049860, 2049865, 2081401, 2081402, 2081403, 2081404, 2099944, 2099945, 2099946, 2099947, 2127355, 2129118, 2129119, 2130231, 2130232, 2134491, 2134492, 2134493, 2141306, 2141307, 2141308, 2141309, 2144228, 2144229, 2147652, 2147653, 2155104, 2155105, 2155106, 2160011, 2160012, 2160013, 2163916, 2163917, 2163918, 2163919, 2170102, 2170103, 2170104, 2171128, 2171129, 2171130, 2171760, 2171761, 2171762, 2172331, 2172332, 2172333, 2173628, 2173629, 2173630, 2173631, 2183120, 2183121, 2183122, 2185350, 2185351, 2185352, 2191886, 2191887, 2191888, 2191889, 2191890, 2198130, 2198131, 2198132, 2198949, 2199846, 2203877, 2204319, 2213562, 2222460, 2227237, 2227238, 2227239, 2227240, 2229344, 2229345, 2229346, 2229347, 2248985, 2248986, 2248987, 2248988, 2249334, 2249335, 2249336, 2249337, 2251008, 2251009, 2251010, 2251011, 2256451, 2256452, 2256453, 2271152, 2271153, 2273866, 2273867, 2273868, 2277908, 2277910, 2277911, 2285794, 2285795, 2292978, 2297156, 2297157, 2301179, 2301180, 2307494, 2307495, 2318277, 2318278, 2318279, 2324946, 2324947, 2326021, 2326022, 2326023, 2332056, 2332057, 2335616, 2335617, 2346791, 2346792, 2347661, 2347662, 2347663, 2347664, 2351984, 2351985, 2352748, 2352749, 2352750, 2357108, 2357109, 2357110, 2368867, 2368868, 2371731, 2377625, 2380684, 2380685, 2382358, 2382359, 2385351, 2385352, 2397444, 2397445, 2399505, 2400640, 2400641, 2400642, 2400643, 2401967, 2401968, 2401969, 2403094, 2403095, 2420433, 2420434, 2420435, 2420436, 2421392, 2421393, 2422953, 2422954, 2424443, 2424444, 2424445, 2424446, 2428301, 2428302, 2428303, 2430949, 2430950, 2430951, 2430952, 2430953, 2432785, 2432786, 2432787, 2434193, 2434194, 2436264, 2436265, 2436266, 2436888, 2444978, 2444979, 2444980, 2445454, 2445455, 2445718, 2445719, 2445720, 2452964, 2452965, 2452966, 2453640, 2453641, 2462689, 2462690, 2462691, 2479621, 2479622, 2481545, 2481546, 2481547, 2481548, 2483939, 2483940, 2483941, 2485546, 2485548, 2495527, 2495528, 2510500, 2510501, 2510502, 2512119, 2512120, 2516200, 2516201, 2516202, 2516203, 2519789, 2526288, 2526289, 2526290, 2539337, 2539338, 2539339, 2539340, 2539341, 2539342, 2539343, 2545543, 2545544, 2550534, 2550535, 2554567, 2554568, 2556710, 2556711, 2556712, 2564381, 2564382, 2564383, 2565655, 2565656, 2565657, 2565659, 2565660, 2565661, 2565662, 2568307, 2568308, 2568309, 2579009, 2582612, 2582613, 2585552, 2585553, 2585554, 2601937, 2609823, 2609824, 2610290, 2610291, 2610292, 2611258, 2611259, 2611260, 2611809, 2611810, 2611811, 2614559, 2623951, 2628478, 2628479, 2632169, 2635290, 2642701, 2642704, 2644645, 2645580, 2645581, 2649167, 2653724, 2657668, 2663615, 2688427, 2688428, 2699914, 2699915, 2699916, 2703694, 2703695, 2706181, 2706182, 2712302, 2712303, 2712735, 2712736, 2716519, 2717772, 2717773, 2719080, 2723278, 2723538, 2723539, 2731624, 2731625, 2731626, 2731627, 2747906, 2747907, 2747908, 2747909, 2747910, 2755604, 2755605, 2755606, 2765194, 2765195, 2765196, 2775706, 2775707, 2780741, 2780742, 2785560, 2785561, 2785562, 2785563, 2795336, 2815284, 2815285, 2816988, 2816989, 2816995, 2816996, 2826558, 2826559, 2837891, 2837892, 2837893, 2840497, 2840498, 2845054, 2845055, 2845737, 2845738, 2850555, 2850556, 2858311, 2858312, 2858965, 2858966, 2859573, 2859574, 2868805, 2868806, 2868807, 2881148, 2881149, 2881150, 2881151, 2881152, 2903829, 2903830, 2903831, 2917986, 2917987, 2917988, 2917989, 2925333, 2925334, 2925335, 2937749, 2937750, 2944063, 2944066, 2944067, 2954926, 2954927, 2955658, 2955659, 2963234, 2963235, 2970486, 2970487, 2981570, Y3JD91, Y3JEA1, Y57F71 and Y5CHS1000.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide
  • Descripción del producto
    DePuy ASR 100 Acetabular Implant, 56 mm, 999800756, sterile, DePuy International, Ltd, Leeds, United Kingdom.
  • Manufacturer
    Depuy Orthopaedics, Inc.

Manufacturer

Depuy Orthopaedics, Inc.
  • Dirección del fabricante
    Depuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Source
    USFDA