Events

Rappel de Device Recall MODEL: Aegis Torque Handle CATALOG NO. : 287110800

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 DePuy Spine, Inc..

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
    72654
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0454-2016
  • Date de mise en oeuvre de l'événement
    2015-11-20
  • Date de publication de l'événement
    2015-12-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141825
  • 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
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Cause
    Manufacturing error within the torque handle may prohibit some handles from being able to fully assemble with the tightener shaft. the design of the inspection gage does not account for the additional shift length.
  • Action
    DePuy sent an Urgent Voluntary Product Recall Notification dated November 17, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were asked to do the following: 1. Review inventory located within your facility and quarantine any products listed in this recall notice. Please contact your DePuy Synthes Spine* Sales Consultant to return any inventory located within your facility. 2. Review, complete, sign and return the attached business reply form to in accordance with the directions on the business reply form within 5 business days of receipt of this notification. 3. Forward this notice to anyone in your facility that needs to be informed. 4. If any product listed below has been forwarded to another facility, contact that facility and provide them with this letter. 5. Keep a copy of this notice. For further questions please call (508) 828-3774

Device

Device Recall MODEL: Aegis Torque Handle CATALOG NO. : 287110800
  • Modèle / numéro de série
    LOT NUMBER: GB0906 GB0707 GB0907 GB58815 GB59244 GB61134
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY.
  • Description du dispositif
    Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
  • Manufacturer
    DePuy Spine, Inc.

Manufacturer

DePuy Spine, Inc.
  • Adresse du fabricant
    DePuy Spine, Inc., 325 Paramount Dr, Raynham MA 02767-5199
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA