Events

Rappel de Device Recall GHK

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 Implant Direct Sybron Manufacturing, 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
    78583
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0283-2018
  • Date de mise en oeuvre de l'événement
    2017-11-15
  • Statut de l'événement
    Completed
  • 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=159820
  • 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
    Accessories, implant, dental, endosseous - Product Code NDP
  • Cause
    The spectra system/legacy guided surgery handle kit had guided handle inserts that were out of implant direct specifications, from the results of complaints submitted by clinicians regarding the 3.4mm guide insert that will not allow the 3.4 drill to pass through, since the diameter is too small. in addition, the 2.3mm guide was too large.
  • Action
    On November 22, 2017, the recalling firm will send consignees customer letters with replacement product, requesting nonconforming product to be returned to Implant Direct with return labels and packaging. The recalling firm will then initiate calls 24 hours after the communication is sent to the clinician; initiate second calls 72 hours after the communication is sent; and initiate third calls 5 working days after the communication is sent. For further questions, please call (818) 444-3300.

Device

Device Recall GHK
  • Modèle / numéro de série
    Lot # 38665, 38825, 42562, 42649, 43810, 45014, 46950, 50165, 45018, 50165, 52360, 52987, 60376, 62435, 64245, 67044, 73431, 73729, 74772, 70293
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Europe, Canada, Australia, Egypt, Jordan, and Lebanon.
  • Description du dispositif
    Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) || Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consists of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.
  • Manufacturer
    Implant Direct Sybron Manufacturing, LLC

Manufacturer

Implant Direct Sybron Manufacturing, LLC
  • Adresse du fabricant
    Implant Direct Sybron Manufacturing, LLC, 3050 E Hillcrest Dr, Westlake Village CA 91362-3171
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA