Events

Rappel de Device Recall Triathlon TS Femoral Trial

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 Stryker Howmedica Osteonics 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
    47400
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1574-2008
  • Date de mise en oeuvre de l'événement
    2008-03-05
  • Date de publication de l'événement
    2008-07-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-10-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69396
  • 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
    Orthopedic Manual Surgical Instrument - Product Code LXH
  • Cause
    Sharp edges will cause a glove to tear and cut someone. sharp edges on the slots machines in select lots of the triathlon ts femoral trials, sizes 1-8, have been discovered.
  • Action
    Stryker Branches/Agencies were notifed by letter (Urgent Product Recall) on March 5, 2008. Reps were asked to examine inventory and visit hospitals that were provided with the device to retrieve product. Reps were instructed to retrieve all of the affected product lots and return them to their branch or agency warehouse for reconciliation. All products should be reconcilied on the Product Accountability Form that is attached to the letter and sent via Inter-Org Transfer back to Stryker Orthopaedics. Questions and re-orders of the product that is being returned should be directed to 201-831-5825.

Device

Device Recall Triathlon TS Femoral Trial
  • Modèle / numéro de série
    Lot code WFLV
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution --- including states of CT, NJ, PA, VA, NC, GA, FL, AL, MI, MN, IL, TX and AZ.
  • Description du dispositif
    Triathlon TS Femoral Trial; || Size 2 Left || Non-Sterile || Catalog Number 5512-T-201 || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 || Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA