Events

Rappel de Device Recall KyphX HVR Bone Cement

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 Medtronic Spine LLC, formerly Kyphon 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
    54384
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1624-2011
  • Date de mise en oeuvre de l'événement
    2009-11-10
  • Date de publication de l'événement
    2011-03-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-03-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88373
  • 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
    Cement, bone, vertebroplasty - Product Code NDN
  • Cause
    Product may not reach proper viscosity (dough state) and inconsistency or lack of homogeneity during cement preparation and during delivery period.
  • Action
    The firm, Medtronic Spine LLC, sent an "URGENT DEVICE RECALL NOTICE" dated November 9, 2009 to the customers. The notice described the product, problem and actions to be taken. The customers were instructed to return the affected lots to Medtronic Spine; to not use any of the affected product that they may have received (Medtronic will replace any affected product in their inventory), the customer should contact their Medtronic Spine sales representative or customer service at [866-959-7466 or for geography] for assistance with replacement product, and complete and return the URGENT DEVICE RECALL NOTICE: Action Required form to Medtronic Spine LLC via fax at (408) 543-6192 or mail to: Medtronic Spine LLC, Attn: Recall Coordinator, 1221 Crossman Avenue, Sunnyvale, CA 94089. If you have any questions about this notification, please do not hesitate to contact Sr. Director, Regulatory Affairs via email: pamela.n.segale@medtronic.com or phone at (408) 548-5235.

Device

Device Recall KyphX HVR Bone Cement
  • Modèle / numéro de série
    Lot Numbers: EL15106, EL15406, EL15706, EL16006, EL16406, EL16506, EL16806, EL17006, EL17307, EL17507, EL17607, EL17707, EL17807, EL18007, EL18307, EL18407, EL18707, EL18907, EL19207, EL19507, EL19807, EL20007, EL20107, EL20307, EL20407, EL20507, EL20607, EL20808, EL20908, EL21008, EL21208, EL21308, EL21608, EL21708, EL21908, EL22008, EL22108, EL22308, EL22908, EL23008, EL23508, EL23608, EL23708, EL24008, 24108, EL24208, EL24408, EL24508, EL24608, EL25008, EL25108, EL25408, EL25508, EL26409, EL26509
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    USA including states of: AL, AR, AZ, CA, CO, DC, FL, GA, IA, IN, KY, MA, MD, MO, MT, NC, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries including: Argentina, Austria, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Ivory Coast, Jordan, Kuwait, Lebanon, Luxembourg, Lybia, Malaysia, Malta, Mexico, Morocco, Netherlands, New Caledonia, Norway, Panama, Philippines, Poland, Portugal, Puerto Rico, Reunion, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Turkey, United Arab Emirates, United Kingdom and Vietnam.
  • Description du dispositif
    Medtronic brand KyphX HV-R Bone Cement, a polymethyl bone cement consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1A; Manufactured by Elmdown LTD, London, England, for Medtronic Spine LLC, Sunnyvale, CA. || Product is a medical device used during balloon kyphoplasty to cement structures in fractured vertebral bodies.
  • Manufacturer
    Medtronic Spine LLC, formerly Kyphon Inc

Manufacturer

Medtronic Spine LLC, formerly Kyphon Inc
  • Adresse du fabricant
    Medtronic Spine LLC, formerly Kyphon Inc, 1221 Crossman Ave, Sunnyvale CA 94089-1103
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA