Events

Rappel de Symmetric Total Knee Femoral Component

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 Signal Medical 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
    69420
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0111-2015
  • Date de publication de l'événement
    2014-10-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130498
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Cause
    Packaging of a device was compromised.
  • Action
    Signal Medical sent a Notice letter dated September 30, 2014 to customers. Customers were instructed to carefully inspect devices to ensure package integrity before using. If packaging is compromised it should not be used. Return the affected device and packaging to Signal Medical Corporation. Replacement devices with new packaging configuration is shipped to each location with the old packaging configuration in the event that the packaging is found to be compromised. For questions contact Signal Medical Corp. at 1-800-246-6324.

Device

Symmetric Total Knee Femoral Component
  • Modèle / numéro de série
    Catalog # 22-01-02106; Lot # 1110; Serial # L0259; Size 6R  Catalog #22-01-02106; Lot # 2910; Serial # L0533; Size 6R  Catalog # 22-01-02003, Serial #s L0280,L0283, L0284, L0285, L0287, L0288, L0615, Size 3 L  Catalog # 22-01-02004, Serial # l0358, Size 4L  Catalog # 22-01-02005, Serial # L0809; Size 5L  Catalog #22-01-02006; Serial #s L0692, L0842, L0485, L0483, L0486, L0841, L0844, L0847, Size 6L  Catalog # 22-01-02007, Serial #s L0721, L0786, L0787, L0770, L0772, L0775, Size 7L  Catalog #22-01-02103, Serial #s L0265, L0272, Size 3R  Catalog # 22-01-02104, Serial #s L0479, L0515, L0517, Size 4R  Catalog # 22/01-02106, Serial # L0338, L0508, L0537, L0853, L0867, L0872, L0873, Size 6R  Catalog #22-01-02107, Serial #s L0749, L0758, L0760, L0755, L0759, L0762, Size 7R
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama.
  • Description du dispositif
    Symmetric Total Knee Femoral Components || Product Usage: || Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
  • Manufacturer
    Signal Medical Corporation

Manufacturer

Signal Medical Corporation
  • Adresse du fabricant
    Signal Medical Corporation, 400 Pyramid Dr, Marysville MI 48040-2463
  • Société-mère du fabricant (2017)
    Signal Medical Corporation
  • Source
    USFDA