Events

Rappel de Device Recall ORTHOCORD One Violet and One Blue Braided Composite Suture with MO7 Taper Needles

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 Mitek, Inc., a Johnson & Johnson Co..

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
    64706
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1174-2013
  • Date de mise en oeuvre de l'événement
    2013-03-22
  • Date de publication de l'événement
    2013-04-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-02-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116834
  • 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
    Suture, surgical, absorbable, polydioxanone - Product Code NEW
  • Cause
    The ifu provided with the free strand orthocord sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. while this statement is true for violet orthocord sutures, it is an inaccurate statement for blue orthocord free strand sutures. based on in-vivo strength retention study, a blue orthocord sutures maintain approximately 80% of strength at six.
  • Action
    On March 22, 2013, firm notified consignees of recall via letter. Consignees were informed of the following: The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six weeks after implantation. As Blue and Violet ORTHOCORD free strand sutures share the same IFU, IFU-108147 will be revised. Consignees were requested to confirm the receipt of the letter by March 29, 2013.

Device

Device Recall ORTHOCORD One Violet and One Blue Braided Composite Suture with MO7 Taper Needles
  • Modèle / numéro de série
    ALL from Jan 1 2010 - Corrected IFU implementation date
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. || For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
  • Manufacturer
    DePuy Mitek, Inc., a Johnson & Johnson Co.

Manufacturer

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