Events

Rappel de Device Recall Exogen Express Bone Healing System

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 Smith & Nephew 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
    52228
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1696-2009
  • Date de mise en oeuvre de l'événement
    2009-06-05
  • Date de publication de l'événement
    2009-08-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-11-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82573
  • 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
    Exogen Express Bone Healing System - Product Code LPQ
  • Cause
    Problems with transducer may result in a reduced ultrasound output.
  • Action
    All affected Smith & Nephew consignees and distributors were notified of problem and the recall by letters (dated June 5, 2009 and June 8, 2009) via US mail. Patients were directed to return the instruments; physicians were informed that their patients were being contacted; and distributors were requested to return their stock and to notify anyone to whom the product was distributed to also return the product. Direct questions to Smith & Nephew, Inc. by calling at 1-800-836-4080.

Device

Device Recall Exogen Express Bone Healing System
  • Modèle / numéro de série
    Part number 71034200 (system), Serial numbers: 0408017701, 0408017702, 0408017703, 0408017704, 0408017705, 0408017706, 0408017707, 0408017708, 0408017709, 0408017710, 0408017711, 0408017712, 0408017713, 0408017714, 0408017715, 0408017716, 0408017717, 0408017718, 0408017719, 0408017720, 0408017721, 0408017722, 0408017723, 0408017724, 0408017725, 0408017726, 0408017727, 0408017728, 0408017729, 0408017730, 0408017731, 0408017732, 0408017733, 0408017734, 0408017735, 0408017736, 0408017737, 0408017738, 0408017739, 0408017740, 0408017741, 0408017742, 0408017743, 0408017744, 0408017745, 0408017746, 0408017747, 0408017748, 0408017749, 0408017750, 0109000456, 0109000457, 0109000458, 0109000459, 0109000461, 0109000485, 0109000495 and 0109000496 and  Exogen Express Part number 71034140 (device only), Serial numbers: 0408017129, 0408017132, 0408017133, 0408017138, 0408017147, 0408017155, 0408017157, 0408017158, 0408017161, 0408017162, 0408017168, 0408017171, 0408017175, 0408017178, 0408017184, 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  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, Switzerland, Canada, Malaysia, Japan, and UK.
  • Description du dispositif
    Exogen Express Bone Healing System, SAFHS, Part Numbers 71034200 and 71034140, Rx only, Smith & Nephew, 1450 Brooks Road, Memphis TX 38116. These are distributed internationally only. || The device is used for the non-invasive treatment of established nonunions excluding skull and vertebra.
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc
  • Adresse du fabricant
    Smith & Nephew Inc, 1450 E. Brooks Rd, Memphis TN 38116
  • Société-mère du fabricant (2017)
    Smith & Nephew plc
  • Source
    USFDA