Events

Rappel de Device Recall PERPOS Driver

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 Interventional 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
    58461
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0047-2012
  • Date de mise en oeuvre de l'événement
    2011-02-03
  • Date de publication de l'événement
    2011-10-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99403
  • 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
    Orthopedic Screwdriver - Product Code HXX
  • Cause
    This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone. use of this product may result in a delay of the surgical procedure.
  • Action
    Interventional Spine, Inc. sent an "Urgent Recall" letter dated March 15, 2011 to all affected customers. The letter included; affected product, reason for recall and recommendations. Customers were asked to immediately examine inventory, quarantine affected product and to notify International Spine, Inc if any product remain. For information on this recall contact the firm at (949) 472-0006.

Device

Device Recall PERPOS Driver
  • Modèle / numéro de série
    DRIVER CATALOG NO. 6112; 050507A, 061509A, 071808A, 112507A, 042709E
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Word wide Distribution: (USA) Nationwide including the states of CO, CT, FL, KY, LA, MA, NC, NY, OK, OR, TN, TX, VA, and WI; and the countries of Italy, Spain, Turkey, and the U.K.
  • Description du dispositif
    PERPOS Driver; Catalog # 6112 || Interventional Spine, Inc. || A cannulated, driver to be used over a K-wire to engage the head of the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) and drive it into the bone. The PERPOS Driver (61 12) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02), a component of the Reusable BONE-LOK PLS System (9039-01, 9039-02), or as a stand-alone tool.
  • Manufacturer
    Interventional Spine Inc

Manufacturer

Interventional Spine Inc
  • Adresse du fabricant
    Interventional Spine Inc, 13700 Alton Pkwy Ste 160, Irvine CA 92618-1618
  • Société-mère du fabricant (2017)
    Interventional Spine Inc.
  • Source
    USFDA