Events

Rappel de Device Recall MAYFIELD Base Unit

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
    63776
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0558-2013
  • Date de mise en oeuvre de l'événement
    2012-11-05
  • Date de publication de l'événement
    2012-12-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-02-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114754
  • 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
    Accessories, operating-room, table (kit) - Product Code FWZ
  • Cause
    An investigation of an adverse trend of complaints conducted by integra lifesciences identified various product performance issues which could impact the functionality of the firm's mayfield composite series base units and mayfield skull clamps. in order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the base units and skull clamps that were d.
  • Action
    Integra issued an 'Urgent: Voluntary Medical Device Recall Notification with 'Recall Acknowledgment and Return Form' to all Integra Sales Representatives and Customers via visit and E-mail on November 5, 2012. The recall notice informs the customers of the firm's receipt of complaints pin-pointing quality issues with the MAYFIELD Base Units and MAYFIELD Skull Clamps which may impair their functionality. The customers are asked to sign and return the enclosed Recall Acknowledgement and Return Form so as to document their receipt of the recall notification and replacement products. The replacement products are to be delivered by the Integra NeuroSpecialist who is also responsible for returning the signed forms to Integra as documentation that the recalled devices have been replaced. Should the customer(s) have questions or concerns, they are directed to contact Integra Customer Service at: 1-877-444-1114,Option 3 for Technical Support.

Device

Device Recall MAYFIELD Base Unit
  • Modèle / numéro de série
    The recalle product is identified with the Lot Numbers: 097547 and 096546.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA TN, TX, UT, VA, WA and WI.
  • Description du dispositif
    MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. || The MAYFIELD Base Unit (A3101) 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. A Swivel Adaptor (A3018) is an integral component of the Base Unit A3101.
  • Manufacturer
    Integra LifeSciences Corporation

Manufacturer

Integra LifeSciences Corporation