Events

Rappel de Device Recall Nobel Replace Tapered Groovy RP 4.3x10mm

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 Nobel Biocare USA 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
    48702
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2240-2008
  • Date de mise en oeuvre de l'événement
    2007-11-02
  • Date de publication de l'événement
    2008-09-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-09-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71930
  • 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
    Implant, endosseous, root-form - Product Code DZE
  • Cause
    This recall was initiated after it was discovered that the nobelreplace tapered groovy rp 4.3x10mm, ref 32216 lot#403504 has an incorrect cap label. the affected lot has a cap label identifying the implant as "4.3x8". since this cap label may be the only means used for identifying the implant prior to surgery, it is possible that a user would try to use the 10mm implant as an 8mm implant.
  • Action
    The recall was initiated on 11/02/2007 with telephone calls to the affected customers. A "Urgent Medical Device Recall" letter with attached Customer Response form was then sent via US Postal Service beginning on 11/02/2007. The letter instructed customers to please immediately remove and return REF 32216 Lot #403504, NobelReplace Tapered Groovy RP 4.3x10mm. The firm contracted UPS courier service to pick up the recalled products. Customers were also instructed if the have further distributed the affected product to please immediately notify those customer to cease using this particular lot and forward the customer this notice. The firm indicated in the recall notice that they are in the process of sending out replacement products. Contact Kam Leung at 714-282-4800 if you have questions.

Device

Device Recall Nobel Replace Tapered Groovy RP 4.3x10mm
  • Modèle / numéro de série
    Ref 32216 lot number: 403504
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    AR, AZ, CA, CO, FL, GA, IA, IL, MA, ME, MI, MO, NC, NC, NJ, NY, OK, PA, TX, UT, VA, WA
  • Description du dispositif
    NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to support for prosthetic devices.
  • Manufacturer
    Nobel Biocare USA LLC

Manufacturer

Nobel Biocare USA LLC
  • Adresse du fabricant
    Nobel Biocare USA LLC, 22715 Savi Ranch Pkwy, Yorba Linda CA 92887-4609
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA