Events

Rappel de Device Recall Prima Plus

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 Keystone Dental 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
    80112
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2162-2018
  • Date de mise en oeuvre de l'événement
    2018-05-01
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164567
  • 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 implants are mislabeled.
  • Action
    The Firm sent an Urgent Medical Device Correction letter dated April 30, 2018. In this discrepancy, the 5 is missing from the implant length description. Please note this discrepancy is limited to the implant package label only. The patient chart labels are all correct. Keystone Dental has performed a thorough review and determined there are no health hazards associated with this issue. There is no issue with the product within the package and the product can be safely used without issue in accordance with the defined surgical protocols. There is no risk of confusion of product size. The diameter is correct. Prima Plus implants are only available in 11.5mm lengths. The catalogs, surgical protocols and manuals only define procedures and provide instrumentation for placing 11.5mm length implants. Additionally, the patient chart labels contained within the implant package are correct so that patient procedure history will be properly maintained. The issue is limited to the label on the outside of the product package only. The lot identified above is the only affected lot. No other lots are affected with this issue. The product referenced above can be used safely without issue and no further action is required. For further questions, please call (866) 902-9272.

Device

Device Recall Prima Plus
  • Modèle / numéro de série
    UDI: D76815737K0, Lot 37038
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to the states of : CA, CT, FL, IN, MA, MD, MI, MN, MT, NJ, NV, NY, TX, and VA.
  • Description du dispositif
    Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K || Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
  • Manufacturer
    Keystone Dental Inc

Manufacturer

Keystone Dental Inc
  • Adresse du fabricant
    Keystone Dental Inc, 154 Middlesex Tpke, Burlington MA 01803-4403
  • Société-mère du fabricant (2017)
    Keystone Dental Inc
  • Source
    USFDA