Events

Rappel de "LOCATOR Abutment for 5.7 ScrewVent Compatibles"

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 Zest Anchors 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
    48645
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0298-2009
  • Date de mise en oeuvre de l'événement
    2008-04-09
  • Date de publication de l'événement
    2008-12-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-12-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71791
  • 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
    Endosseous, root-form implant - Product Code DZE
  • Cause
    The recall was initiated after the firm discovered through a customer complaint that the locator abutments for 5.7 screw-vent & compatibles do not fit properly in all sizes of the zimmer dental 5.7mm diameter tapered screw-vent implants (tsv6b8, tsv6b10, tsv6b11, tsv6b13, tsv6b16, tsv6h8, tsv6h10, tsv6h11, tsv6h13 and tsv6h16). the locator abutment bottoms out in the pilot hole of these implants c.
  • Action
    The recall notification letter (Recall Notice) was sent to consignees on April 23,2008. The letter includes the following information on how to handle the recall. It is very important that you determine the use of the Locator Abutment(s) as follows, mark the appropriate box, ,and return this letter to Zest Anchors, Inc. in the stamped, self-addressed envelope: 1. The Locator Abutment(s) listed above WERE NOT used on any Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implants. THE FIT IS CORRECT AND NO ACTION IS NECESSARY. 2. The Locator Abutment(s) listed above WERE used on a Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implant. PLEASE CONTACT OUR DENTAL OFFICE TO ARRANGE THE R PLACEMENT OF THE ABUTMENT WITH A NEWLY DESIGNED LOCATOR ABUTMENT. and 3. We have current STOCK of the Locator Abutment(s) listed above with planned use for a Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implant. PLEASE CONTACT OUR DENTAL OFFICE TO ARRANGE THE REPLACEMENT OF THE ABUTMENT WITH A NEWLY DESIGNED LOCATOR ABUTMENT. For questions or additional information, contact Zest Anchors, Inc. at 800-262-2310 or 760-743-7744.

Device

"LOCATOR Abutment for 5.7 ScrewVent Compatibles"
  • Modèle / numéro de série
    Product Codes: 8190 (1.0 mm), 8191 (2.0 mm), 8192 (3.0mm), 8193 (4.0mm), 8194 (5.0 mm) and 8195 (6.0mm).
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution including USA and countries of Spain, Canada, Australia and South Africa.
  • Description du dispositif
    "LOCATOR Abutment for 5.7 Screw-Vent & Compatibles." Zest Anchors, Inc. Product is sold for use with any Zimmer Dental 5.7 mm diameter Tapered Screw-Vent Implant. || The product is used with supra-gingival, universal hinge, resilient overdenture attachment for endosseous implants.
  • Manufacturer
    Zest Anchors Inc

Manufacturer

Zest Anchors Inc
  • Adresse du fabricant
    Zest Anchors Inc, 2061 Wineridge Pl, Escondido CA 92029-1947
  • Société-mère du fabricant (2017)
    Zest Anchors Inc.
  • Source
    USFDA