Events

Rappel de Device Recall Mayfield Infinity XR2

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 Integra LifeSciences Corporation.

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
    55852
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2336-2010
  • Date de mise en oeuvre de l'événement
    2010-05-19
  • Date de publication de l'événement
    2010-09-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92040
  • 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
    Operating Room Accessories Table Tray - Product Code FWZ
  • Cause
    Storage case incorrectly labeled. the labels were for the infinity xr2 skull clamp storage containers but were inadvertently placed on the infinity xr2 base unit storage cases.
  • Action
    The firm, Integra Life Sciences Corporation,contacted their customers via telephone and Field Correction Letter on May 19, 2010 to notify their customers of the problem. The firm indicated that their sales representatives will visit the consignees affected, correct the case labeles according to the specific instructions indicated, revise their account tracebility records to reflect the labeling change, then, sign and return the Acknowledgement of Reciept and Return Form for confirmation. For questions regarding the correction, please contact Integra Life Sciences Corporation at (877) 44-1114 or (513) 533-7923.

Device

Device Recall Mayfield Infinity XR2
  • Modèle / numéro de série
    Reference number A-2079, Serial number(s) XB091031, XB091032, XB091033, XB091034, XB091035, XB091036, XB091037, XB091038, XB091039, XB091040, XB091041, XB091042, XB091043, XB091044, XB091045, XB091046, XB091047, XB091048, XB091049, XB091050
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Product was shipped to the following states: IN, MO, NJ, TX and VA. Product was also sold in Belgium, Canada and New Zealand.
  • Description du dispositif
    Mayfield Infinity XR2 Base Unit, model A-2079, manufactured by Integra LifeSciences Corporation. The MAYFIELD Infinity XR2 Base Unit (A-2079) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where x-ray imaging modalities will be used.
  • Manufacturer
    Integra LifeSciences Corporation

Manufacturer

Integra LifeSciences Corporation