Events

Rappel de Device Recall Stryker Orthopaedics Sterile Knee Instrument Disposable Patella Cutter

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
    53858
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0529-2010
  • Date de mise en oeuvre de l'événement
    2009-11-11
  • Date de publication de l'événement
    2009-12-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-08-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86691
  • 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
    Patella Cutter - Product Code HTS
  • Cause
    Disposable patella cutters - 30 mm (catalog number 8000-0030, lot v31257001) were packaged and labeled as 33 mm disposable patella cutters (catalog number 8000-0033, lot v31257001 and vice versa.
  • Action
    An "Urgent Product Recall" letter dated November 11, 2009 was sent to all affected Stryker branches, hospital risk management, hospital Chief or Orthopaedics and surgeons by Federal Express. The letter described the issue, potential hazards and risk mitigation factors and requested that the Recall Acknowledgement form be completed and returned. The Recall Acknowledgement form has information regarding the return of affected product to the firm. Direct questions to Stryker Orthopaedics by calling 1-201-831-5832.

Device

Device Recall Stryker Orthopaedics Sterile Knee Instrument Disposable Patella Cutter
  • Modèle / numéro de série
    Catalog Number 8000-0033; Lot code V31257001.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution (MA, NJ, FL, TN, OR and NY).
  • Description du dispositif
    Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter; || Stainless Steel, Disposable; || Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 || 33 mm size, One single unit to a package. || Note: The 30 mm instruments were not distributed. || The patella cutters are components of the Xcelerate Instruments and are used with additional devices to remove bone from the patella in preparation for a replacement implant. The Xcelerate Patella Reaming Instruments provide a means to prepare for implantation of either the Duracon or Scorpio Total Knee Systems patellar implants.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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