Events

Rappel de Device Recall Extremity Medical Disposable Instrument 1.6 mm Guidewire

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 Extremity Medical 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
    64330
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0952-2013
  • Date de mise en oeuvre de l'événement
    2013-01-10
  • Date de publication de l'événement
    2013-03-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115841
  • 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
    Passer, wire, orthopedic - Product Code HXI
  • Cause
    The 1.6 mm guidewire is undersized up to 2 mm in length. when used with the depth gauge, the measurement reading will not correspond with the desired screw length. the selected screw size based on the depth gauge reading will be about 2 mm longer than intended.
  • Action
    Extremity Medical sent an "URGENT: FIELD SAFETY NOTICE" dated January 10, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Response Form was included for customers to complete and return. Contact Customer Service at 1 (973) 588-8980 for questions regarding this notice. On April 10, 2013, Extremity sent notifications to their customers at the surgeon level. They were asked to complete the attached product field action response form.

Device

Device Recall Extremity Medical Disposable Instrument 1.6 mm Guidewire
  • Modèle / numéro de série
    Catalog Number 101-00006; Lot Number 00921538.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA including the states of Florida, Pennsylvania, New Hampshire, Oklahoma, California, Maryland, Arizona, Ohio, North Carolina, Texas, Virginia, Illinois, New York and Tennessee, and the countries of Australia, Belgium, Israel, Netherlands and United Kingdom.
  • Description du dispositif
    Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge.
  • Manufacturer
    Extremity Medical LLC

Manufacturer

Extremity Medical LLC
  • Adresse du fabricant
    Extremity Medical LLC, 300 Interpace Pkwy Ste 410A, Parsippany NJ 07054-1148
  • Société-mère du fabricant (2017)
    Extremity Medical Llc
  • Source
    USFDA