Events

Rappel de ELAN 4 Air System

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 Aesculap Implant Systems LLC.

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
    79092
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0623-2018
  • Date de mise en oeuvre de l'événement
    2017-09-01
  • Date de publication de l'événement
    2018-02-15
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161326
  • 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
    Motor, drill, pneumatic - Product Code HBB
  • Cause
    The elan 4 air system was released to the market place prior to an authorized fda 510k clearance. this issue does not affected sales outside the united states (ous).
  • Action
    On September 1, 2017 an Urgent Medical Device Recall letter was issued to customers for the ELAN 4 Air System which includes the following sub-components: ST0607 ELAN 4 Air Control Set ST0608 ELAN 4 Air Neuro Crani Set ST0609 ELAN 4 Air Spine Set ST06411 ELAN 4 Air HD Spine Set ST0614 ELAN 4 Air Micro Saw Set ST0615 ELAN 4 Air Hand Control Set ST0638 ELAN 4 Air Large Saw Set The letter directs customers to take the following actions: 1. Review the Voluntary Urgent Medical Device Recall Notification Letter in its entirety and ensure that all users in your organization and other concerned persons are informed about this recall and immediately discontinue use. 2. Determine your current inventory of affected products within your facility. Immediately remove the affected products and return to Aesculap Inc. Do not destroy any affected products. 3. Utilizing the attached Product Recall Acknowledgement Response Form on the next page of this letter, record the total number of products in your possession. If you have no inventory remaining, please enter zero (0) on the form and a REASON WHY (example, returned evaluation system to sales representative). 4. Please contact Customer Service and they will provide you with a Returned Goods number and return label. Customer Service: 1-800-282-9000 aesculap_emailorders.bbmus_service@bbraun.com

Device

ELAN 4 Air System
  • Modèle / numéro de série
    ELAN 4 Air System  ST0607 ELAN 4 Air Control Set  ST0608 ELAN 4 Air Neuro Crani Set  ST0609 ELAN 4 Air Spine Set  ST06411 ELAN 4 Air HD Spine Set  ST0614 ELAN 4 Air Micro Saw Set  ST0615 ELAN 4 Air Hand Control Set  ST0638 ELAN 4 Air Large Saw Set
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
  • Manufacturer
    Aesculap Implant Systems LLC

Manufacturer

Aesculap Implant Systems LLC
  • Adresse du fabricant
    Aesculap Implant Systems LLC, 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Société-mère du fabricant (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA