Events

Rappel de Device Recall Reverse Shoulder Prosthesis device components

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 Encore Medical, Lp.

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
    37874
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1246-2007
  • Date de mise en oeuvre de l'événement
    2007-03-22
  • Date de publication de l'événement
    2007-09-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-03-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52015
  • 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
    Prosthesis device components - Product Code KWS
  • Cause
    Marketed without approval: investigational devices were implanted during an ide study prior to receiving approval for the devices in the study; patients were implanted with investigational devices outside of the ide study; and devices implanted as "custom devices" by the manufacturer did not meet the definition of "custom devices" and were, therefore, unapproved devices.
  • Action
    Letters were sent via Certified Mail on 03/22/07 to the surgeons and their associated IRBs. Each letter included a list of the patients to be notified and a form letter that the surgeons could use to notify the patients. Surgeons asked to notify their patients and to provide Encore with documented evidence that patience were notified.

Device

Device Recall Reverse Shoulder Prosthesis device components
  • Modèle / numéro de série
    0700-031.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide: Devices sold to and implanted by physicians in CA, CO, FL, GA, NY, SC and TX.
  • Description du dispositif
    Reverse Shoulder Prosthesis (RSP) custom device component; 30mm Locking Screw; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Adresse du fabricant
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA