Events

Rappel de Device Recall ConMed Detacha Tip

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 Conmed Corporation.

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
    35949
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1433-06
  • Date de mise en oeuvre de l'événement
    2006-03-27
  • Date de publication de l'événement
    2006-08-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47250
  • 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
    Laparoscopic instrument - Product Code GEI
  • Cause
    Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures.
  • Action
    On 3/27/06, all domestic customers were sent an "URGENT DEVICE RECALL" notice, dated 3/27/06, by USPS Priority Mail (Delivery Confirmation). International customers were notified by facsimile and/or e-mail as well as by mail.

Device

Device Recall ConMed Detacha Tip
  • Modèle / numéro de série
    Product Code: 1-1008; all lot codes manufactured between 10/20/2003 and 2/16/2005. Each lot code is found on the package labeling of unopened units and is also embossed on the grey hub of the device. For 5 digit lot codes: the 1st digit represents the year (4 represents 2004), the 2nd & 3rd digits represent the month (09 for September), and the 4th & 5th digits for the day of the month. For 7 digit lot codes: the 1st two digits represent the year, the 3rd & 4th represent the month, the 5th & 6th represent the day of the month, and the 7th digit represents the manufacturing shift code.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide
  • Description du dispositif
    ConMed DetachaTip Multi-Use Laparoscopic Instrument - "Fenestrated (Duckbill) Multiple Use Grasper", 5 mm x 33 cm, REF/Product code-1-1008. || ------- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
  • Manufacturer
    Conmed Corporation

Manufacturer

Conmed Corporation
  • Adresse du fabricant
    Conmed Corporation, 525 French Rd, Utica NY 13502-5945
  • Source
    USFDA