Events

Rappel de Stryker System 6 Rotary Handpiece

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 Instruments Div. of Stryker 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
    50084
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1024-2009
  • Date de mise en oeuvre de l'événement
    2008-10-10
  • Date de publication de l'événement
    2009-03-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-10-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74689
  • 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
    Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment - Product Code KIJ
  • Cause
    The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
  • Action
    Consignees were notified of the problem via letter dated October 10, 2008, provided interim instructions to reduce the risk, and informed that Stryker instruments will replace the trigger on all handpieces. Consignees were also instructed on the following: 1) Review the letter and distribute to all affected departments, 2) Complete and sign the enclosed Business Reply Form and fax to 336-499-8603 and 3) Call Stryker Instruments Service Department at 888-308-1983 to schedule service for the handpieces.

Device

Stryker System 6 Rotary Handpiece
  • Modèle / numéro de série
    Serial numbers 0615001103 through 0826001573.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.
  • Description du dispositif
    Stryker Rotary Handpiece, Dual Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6205. || The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Adresse du fabricant
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA