Events

Rappel de Device Recall ConMed Linvatech Hall Surgical Blades, Sterile ST BLD BRZL NEXGEN

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 Linvatec Corp..

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
    47848
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0378-2009
  • Date de mise en oeuvre de l'événement
    2008-02-21
  • Date de publication de l'événement
    2009-01-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-01-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70445
  • 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
    Surgical Instrument Motors and Accessories/Attachments - Product Code GET
  • Cause
    Sterility compromised. there is a possibility that certain catalog number and lots of conmed linvatec hall surgical blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
  • Action
    An Urgent Medical Device Recall letter was issued. Customers must check their facility's inventory immediately for the catalog and lot numbers in the attached list. They also need to complete and sign the enclosed Reply Form and mail or fax the Reply Form to ConMed Linvatec using the enclosed self addressed postage paid envelope or fax 727-319-5701. Customers have an option to either re-sterilize the products using the re-sterilization instructions in the letter or they can return the devices to ConMed Linvatec for a credit using the enclosed preprinted FedEx Air Bill with ConMed Linvatec's Bill Number and the return goods number. Recall is being conducted to the distributor and end user level.

Device

Device Recall ConMed Linvatech Hall Surgical Blades, Sterile ST BLD BRZL NEXGEN
  • Modèle / numéro de série
    BBD23053 through BBD23055, BBD23349, BBD24402, BBD24403, BBD24765 through BBD24767, BBD25076 through 25078, BBD25080, BBD30516, BBD30517, BBD31763 through BBD31767, BBD33235, BBD33242, BBD33243, BBD33577, BBD35735, BBD36459, BBD36469, and BBD37131.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    ConMed Linvatec Hall Surgical Blades, Sterile ST BLD BRZL NEXGEN, Catalog #00507120100 || ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries. These blades are designed to cut bone in an oscillating plane.
  • Manufacturer
    Linvatec Corp.

Manufacturer

Linvatec Corp.
  • Adresse du fabricant
    Linvatec Corp., 11311 Concept Boulevard, Largo FL 33773
  • Société-mère du fabricant (2017)
    CONMED Corp.
  • Source
    USFDA