Events

Rappel de Device Recall Holding Forceps for Trident Acetabular System

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
    52384
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0539-2010
  • Date de mise en oeuvre de l'événement
    2007-01-24
  • Date de publication de l'événement
    2009-12-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-12-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82817
  • 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
    Forceps - Product Code HTD
  • Cause
    The tips of the forceps were larger than the positioning holes located on the trials and the implant liners.
  • Action
    Important Product Correction letters, dated January 24, 2007, were sent to all consignees on via Federal Express. The letter stated the problem and asked customers to examine their inventory and hospital locations to identify the affected product. All affected forceps product should be retrieved from hospitals and returned to their branch or agency warehouse for reconciliation. Customers are also to reconcile all affected product on the attached Product Accountability Form and fax a copy of that form to 201-831-6069 within 5 days of receipt of the letter. All affected forceps product is to be destroyed and discarded at their branch location. Questions should be directed to their Stryker Orthopaedics Customer Service rep at 1-866-OR-ASSIST.

Device

Device Recall Holding Forceps for Trident Acetabular System
  • Modèle / numéro de série
    All lots beginning with V1 (XXX).
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- Including countries of Hong Kong, Australia, Japan, New Zealand, Hong Kong, Singapore, Germany, Sweden, The Netherlands, France, Spain, Portugal, and the United Kingdom.
  • Description du dispositif
    Holding Forceps for Trident Acetabular System; non Sterile; || Catalog number 2105-0000; || Howmedica Osteonics Corp, 325 Corporate Drive, || Mahwah, NJ 07430; || Authorized representative in Europe: || Stryker France, Cedex. France || The Holding Forceps for Acetabular trial cups help facilitate the insertion / correction of the Acetabular trial inserts.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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