Events

Rappel de Device Recall Trident

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
    46691
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1172-2008
  • Date de mise en oeuvre de l'événement
    2008-01-21
  • Date de publication de l'événement
    2008-06-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68173
  • 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
    hip prosthesis acetabular component - Product Code MEH
  • Cause
    Foreign material: some of the parts tested exceeded stryker orthopaedics internal acceptance criteria for manufacturing residuals.
  • Action
    Recall notification letters were sent to Stryker Branches/agencies, OR Supervisors and Chief of Orthopaedics on 1/21/08. A Patient information sheet was sent on 2/4/08 to surgeons and hospitals. Per call with Center 2/4/08, recall letter to be revised and RES updated upon receipt. The letter was revised and sent on February 28, 2008 to include Trident PSL Acetabular shells. This letter was sent to Risk Management at hospitals and included the scope of the recall , the potential hazard and recommendation to physicians to monitor patients consistent with care for those receiving total hip replacement. It was also sent to surgeons and a revised letter to Stryker branches. A product acknowledgement form was included in all letters to indicate receipt of letter and quantity of product on hand, if applicable.

Device

Device Recall Trident
  • Modèle / numéro de série
    Catalog Numbers: 500-11-42A; 508-11-4B; 508-11-46C; 508-11-48D; 508-11-50D; 508-11-52E; 508-11-54E; 508-11-56F; 508-11-58F; 508-11-60G; 508-11-62G; 50811-64H; 508-11-66H; 508-11-68I; 508-11-70I; 598-11-72J; 508-11-74J. All lot codes with expiration dates of 1/2005 and 12/2012.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide distribution.
  • Description du dispositif
    Trident Hemispherical Multi || Arc Deposited; || Hydroxylapatite Coated; Multiholed; Use with Size A insert; || hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430
  • 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