Events

Rappel de Device Recall External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3

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 BioHorizons Implant Systems 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
    67090
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1058-2014
  • Date de mise en oeuvre de l'événement
    2013-12-10
  • Date de publication de l'événement
    2014-02-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-03-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124682
  • 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
    The body length of the external implant 40105d3 lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
  • Action
    The firm, BioHorizons, sent an "Urgent Medical Device Recall" letter dated December 10, 2013 to its Consignees. The letter described the product, problem and actions to be taken. The customers were instructed to return unused affected implants and receive replacements free of charge; complete and return the enclosed Customer Reply Form via fax to (205) 484-2195 or scan to PDF and e-mail to implants@biohorizons.com; If you have affected implants, upon receipt of your completed Customer Reply Form, you will be contacted by BioHorizons Customer Care and provided a Return Authorization number. In addition, if you have already placed any affected implants without incident, no special patient action needs to be taken. If you have any questions regarding this information, please contact our Customer Care Department at (888) 246-8338, Monday through Friday, 7:30am to 6:00pm Central Time.

Device

Device Recall External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3
  • Modèle / numéro de série
    Lot Number 1302762, Exp 31 MAY 2018
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: US (nationwide) to states of: LA, CA, NC, IL, PA, and NY; and Internationally to: Seoul, Korea; New Delhi, India; Taipei City, Taiwan; and Madrid, Spain.
  • Description du dispositif
    External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 || Usage: dental
  • Manufacturer
    BioHorizons Implant Systems Inc

Manufacturer

BioHorizons Implant Systems Inc
  • Adresse du fabricant
    BioHorizons Implant Systems Inc, 2300 Riverchase Center, Birmingham AL 35244-2808
  • Société-mère du fabricant (2017)
    Henry Schein Inc
  • Source
    USFDA