Rappel de Device Recall Integra Leyla Ball Joint Clamp

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 Limited.

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
    65824
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2056-2013
  • Date de mise en oeuvre de l'événement
    2013-07-17
  • Date de publication de l'événement
    2013-08-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2014-10-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    Drills, burrs, trephines & accessories (manual - Product Code HBG
  • Cause
    As a result of complaint investigations it was identified that there is a potential that the leyla ball joint clamp (r2383) may not provide the level of stability needed to maintain retraction in all cases.
  • Action
    Integra sent an Urgent Medical Device letter dated July 17, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to review your inventory and determine if you have any of the affected products. If so, stop using them immediately and remove them from your service. When your form is received, Customer Service will you an RMA number and directions for returning the products. Should you have any questions regarding these instructions, please contact Integra Customer Service at 1-800-997-4868.

Device

  • Modèle / numéro de série
    Catalog Number R2383 and as a component of catalog number R2385, including all lot numbers date codes going back to January 2006.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including Puerto Rico and the states of AZ, CA, FL, GA, IL, IN, KY, MA, MI, MS, NE, NM, NY, OH, PA, TN, TX, UT, VA, WA, WI and WV., and the countries of Spain, Singapore, South Africa, Canada, Libya,Pakistan and Cayman Islands.
  • Description du dispositif
    Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. || The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Integra Limited, 311 Enterprise Dr, Plainsboro NJ 08536-3344
  • Source
    USFDA