Events

Rappel de Device Recall Zodiac Polyaxial Spinal Fixation 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 Alphatec 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
    50685
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0491-2010
  • Date de mise en oeuvre de l'événement
    2008-11-03
  • Date de publication de l'événement
    2009-12-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-12-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75994
  • 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 interlaminal - Product Code KWP
  • Cause
    Alphatec spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. as a result, they are conducting a voluntary recall of the zodiac titanium cannulated polyaxial screw 6.5 mm x 50 mm l.
  • Action
    Alphatec Spine contacted consignees via phone on October 16, 2008 and requested that consignees immediately remove the Zodiac Titanium cannulated polyaxial screws (6.5 mm x 50 mm L) from the surgical set to help ensure that they will not be used in surgery. There is a script the company developed to assure consistent responses to customers, and a phone number for more information. The strategy calls for products to be returned to Alphatec Spine. The company will arrange to have Federal Express contact the consignees for pick-up of the screws. Follow up questions are directed to the company at 1-800-922-1356.

Device

Device Recall Zodiac Polyaxial Spinal Fixation System
  • Modèle / numéro de série
    Part Number: 62665-50 Lot Number: 617945
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    AZ, CA, FL, TX
  • Description du dispositif
    Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • Adresse du fabricant
    Alphatec Spine, Inc., 2051 Palomar Airport Rd Ste 100, Carlsbad CA 92011-1462
  • Société-mère du fabricant (2017)
    Alphatec Spine Inc
  • Source
    USFDA