Events

Rappel de Device Recall BIRMINGHAM HIP RESURFACING MODULAR HEAD

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
    72719
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0584-2016
  • Date de mise en oeuvre de l'événement
    2015-11-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142027
  • 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, hemi-, femoral, metal - Product Code KWL
  • Cause
    The 16 devices distributed in the united states were incorrectly labeled as the monoblock birmingham hip modular head, with labeling not cleared for marketing in the us. the actual devices were monoblock modular femoral head for hemiarthroplasty use.
  • Action
    The firm sent their field safety notices on 11/16/2015 by letter delivered by Fed Ex (overnight) and email. Non- responding consignees will be contacted within 4 weeks of the initial notice

Device

Device Recall BIRMINGHAM HIP RESURFACING MODULAR HEAD
  • Modèle / numéro de série
    All codes
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, France, UAE, Austria, Australia, Belgium, CANADA, Switzerland, Germany, Denmark, Spain, Finland, UK, Hong Kong, ISRAEL, India, Italy, Japan, South Korea, Netherlands, Norway, Poland, PORTUGAL, Sweden, SINGAPORE, Thailand, Turkey, and SOUTH AFRICA.
  • Description du dispositif
    BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: || 74121238, MODULAR HEAD 38 MM -8MM || 74121242, MODULAR HEAD 42 MM -8MM || 74121246, MODULAR HEAD 46 MM -8MM || 74121250, MODULAR HEAD 50 MM -8MM || 74121254, MODULAR HEAD 54 MM -8MM || 74121258, MODULAR HEAD 58 MM -8MM || 74121338, MODULAR HEAD 3 8MM -4 (SHORT) || 74121342, MODULAR HEAD 42 MM -4 (SHORT) || 74121346, MODULAR HEAD 46 MM -4 (SHORT) || 74121350, MODULAR HEAD 50 MM -4 (SHORT) || 74121354, MODULAR HEAD 54 MM -4 (SHORT) || 74121358, MODULAR HEAD 58 MM -4 (SHORT) || 74121438, MODULAR HEAD 38 MM +0 (MED) || 74121442, MODULAR HEAD 42 MM +0 (MED) || 74121446, MODULAR HEAD 46 MM +0 (MED) || 74121450, MODULAR HEAD 50 MM +0 (MED) || 74121454, MODULAR HEAD 54 MM +0 (MED) || 74121458, MODULAR HEAD 58 MM +0 (MED) || 74121538, MODULAR HEAD 38 MM +4 (LONG) || 74121542, MODULAR HEAD 42 MM +4 (LONG) || 74121546, MODULAR HEAD 46 MM +4 (LONG) || 74121550, MODULAR HEAD 50 MM +4 (LONG) || 74121554, MODULAR HEAD 54 MM +4 (LONG) || 74121558, MODULAR HEAD 58 MM +4 (LONG)
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Adresse du fabricant
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Société-mère du fabricant (2017)
    Smith & Nephew plc
  • Source
    USFDA