Events

Rappel de Device Recall UCHRAP or Universal Compact Head Ring Adapter Plate

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 Corp..

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
    72068
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0025-2016
  • Date de mise en oeuvre de l'événement
    2015-08-21
  • Date de publication de l'événement
    2015-10-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-10-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139703
  • 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
    Neurological stereotaxic Instrument - Product Code HAW
  • Cause
    Integra identified that the uchrap component (arc adapter plate) would not assemble properly to the uchrar component (arc adapter ring) of the compact head ring adapter due to an error in the manufacturing drawing.
  • Action
    Integra sent an Urgent-Voluntary Medical Device Recall letter dated August 19, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm instructed their customers to: 1. Review your inventory and determine if you have an UCHRAP Adapter Plate with an affected serial number listed on the next page. If you do not, it is not affected and you can continue to use it. 2. If you do have product with a serial number listed on the next page, stop using it immediately and remove it from service. 3. Complete the attached form. If you do not have product with a serial number listed, check the box, I do not have any product with a serial number on the list below. 4. If you do have product with a serial number listed, check the box, I do have product(s) with a serial number below. Circle the lot numbers and record the total quantity of all lot numbers you have. 5. Complete the other information and return it by email or fax as indicated on the form or by providing it to your Integra Neuro Specialist. If an Integra Neuro Specialist has not already done so, Customer Service will contact you and provide an RMA number and directions for returning and replacing the product. Should you have any questions regarding these instructions, please call : (513) 533-7932. For any other questions, please call (609) 936-6822.

Device

Device Recall UCHRAP or Universal Compact Head Ring Adapter Plate
  • Modèle / numéro de série
    Cat. No. UCHRAP; Serial No.s 900, 901, 902, 904, 905, 906
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : NJ, TX and WY., and to the countries of : Algeria, Germany and India.
  • Description du dispositif
    Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.