Events

Rappel de Device Recall DePuy ASR 100 Acetabular Implant, 48 mm

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 Depuy Orthopaedics, Inc..

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
    55575
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2033-2010
  • Date de mise en oeuvre de l'événement
    2010-03-05
  • Date de publication de l'événement
    2010-07-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91223
  • 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
    Prosthesis, hip, semi-constrained (metal uncemented acetabular component) - Product Code KWA
  • Cause
    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joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.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.
  • Action
    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, 48 mm
  • Modèle / numéro de série
    1970062, 1126902, 1126903, 1970061, 1970062, 1970066, 1970067, 2002520, 2043942, 2043943, 2043944, 2064568, 2064569, 2064570, 2064571, 2082802, 2082803, 2082804, 2082805, 2109379, 2109380, 2109381, 2109382, 2132297, 2132298, 2137738, 2137739, 2137740, 2138408, 2138409, 2138410, 2150568, 2150569, 2156765, 2156766, 2156767, 2156768, 2169760, 2169761, 2169762, 2177249, 2177250, 2177251, 2178612, 2179853, 2179854, 2179855, 2179856, 2179857, 2185782, 2185783, 2185784, 2185785, 2185786, 2194767, 2194768, 2194769, 2199841, 2239218, 2239219, 2239220, 2239221, 2245241, 2245242, 2245243, 2245910, 2245911, 2245912, 2272155, 2290696, 2290697, 2290698, 2294233, 2294234, 2301174, 2301175, 2323286, 2323287, 2323288, 2327212, 2336908, 2336909, 2341766, 2341767, 2348538, 2348539, 2348540, 2361436, 2361437, 2361438, 2362995, 2362996, 2363272, 2363273, 2363274, 2375125, 2375126, 2382342, 2385329, 2385330, 2385331, 2397411, 2397412, 2397413, 2397414, 2401888, 2401889, 2401890, 2401891, 2420431, 2420432, 2427277, 2427278, 2427279, 2431916, 2431917, 2431918, 2442975, 2442976, 2442977, 2462686, 2462687, 2462688, 2463827, 2463828, 2463829, 2468574, 2468575, 2479061, 2479062, 2479063, 2479064, 2492116, 2492117, 2494026, 2513689, 2513690, 2513691, 2513692, 2519788, 2523798, 2523799, 2523800, 2523801, 2538235, 2538236, 2549239, 2549240, 2549241, 2551528, 2551529, 2551530, 2551531, 2551532, 2551533, 2569986, 2569987, 2569988, 2569989, 2583610, 2583611, 2583612, 2583613, 2583614, 2596542, 2596543, 2597128, 2612440, 2612441, 2612442, 2615758, 2615759, 2615760, 2615761, 2632673, 2640990, 2643479, 2643480, 2644341, 2644342, 2664870, 2664871, 2669827, 2669828, 2675589, 2719076, 2721229, 2721230, 2745761, 2745762, 2745763, 2745764, 2746963, 2746964, 2746965, 2746966, 2746967, 2773059, 2773060, 2775044, 2775045, 2775046, 2776286, 2776287, 2815990, 2815991, 2821637, 2831578, 2841195, 2845052, 2845736, 2846593, 2854859, 2854860, 2858309, 2858310, 2859568, 2877579, 2877580, 2877581, 2892696, 2892697, 2919288, 2919289, 2934258, 2934262, 2956104, 2956105, 2970484, Y28HX1000 and ZB5GD1.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide
  • Description du dispositif
    DePuy ASR 100 Acetabular Implant, 48 mm, 999800748, sterile, DePuy International, Ltd, Leeds, United Kingdom.
  • Manufacturer
    Depuy Orthopaedics, Inc.

Manufacturer

Depuy Orthopaedics, Inc.
  • Adresse du fabricant
    Depuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Source
    USFDA