Events

Rappel de Device Recall Zimmer 4.1 Trabecular Metal" Dental Implant

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 Zimmer 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
    61481
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1511-2012
  • Date de mise en oeuvre de l'événement
    2012-03-22
  • Date de publication de l'événement
    2012-05-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-12-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108230
  • 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 zimmer dental voluntary device recall resulted from an investigation into the february 2012 complaint involving an apical tip of a 4.1mm d trabecular metal implant which separated from the implant assembly during surgery on a patient with a dense (type d1), thick, inferior border. the recall correction includes adding precautions to the instructions for use regarding the placement of a 4.1mm.
  • Action
    Zimmer sent an Urgent Medical Device Correction notification letter dated April 24, 2012, with an attached Technical Bulletin listing precautions present in the new Informaiton for Use sent to distributors and customers via E-mail and FED EX. Notifications identified the issue and risks found with the device listing responsibilties, precautions, and procedural precautions. Notifications contained directions to forward information to any sub accounts and clinicians. Zimmer had telephone follow-up with each distributor and customer to assure information was received and is understood. Questions should be directed to Technical Service (800)8511-7019 orCustomer Service(760) 929-1300 or Regulatory Affairs at 1-800-854-7019 . For questions regarding this recall call 574-372-4807.

Device

Device Recall Zimmer 4.1 Trabecular Metal" Dental Implant
  • Modèle / numéro de série
    Catalog # TMT4B11: Lot 61926103, 61960168, 61967139, 61978064, 61989032
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • Description du dispositif
    Zimmer Dental Trabecular Metal, TMT4B11 IMP TM 4.1MM MTX FULL,11.5MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA || The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, Page 4 of 6 especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Adresse du fabricant
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA