Events

Rappel de Sternal Saw II Sterile Blades

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 Terumo Cardiovascular Systems 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
    57231
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0968-2011
  • Date de mise en oeuvre de l'événement
    2010-10-20
  • Date de publication de l'événement
    2011-01-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95639
  • 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
    Blade, saw, general, &, plastic surgery, surgical - Product Code GFA
  • Cause
    The firm discovered that some outer box labels contain incorrect information regarding the method of sterilization. the label incorrectly indicates the product was ethylene oxide sterlized but the product actually was sterilzed with gamma radiation.
  • Action
    Terumo Cardiovascular Systems Corporation firm sent out an 'URGENT MEDICAL DEVICE CORRECTION: SAFETY ADVISORY" letter dated October 20, 2010, to the Director of Cardiac Operating Room Services or Operating Room Nurse Manager.. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the Safety Advisory, assure that all users were aware of the notice, and confirm receipt of the Safety Advisory by faxing the attached Customer Response Form to the fax number on the form. For questions regarding this recall call 1-800-521-2818.

Device

Sternal Saw II Sterile Blades
  • Modèle / numéro de série
    0505258, 0510335, 0519809, 0524042, 0531107, 0533191, 0536444, 0538524, 0541634, 0545325, 0547867, 0552336, 0561753, 0561751, 0561752, 0557559, 0564337, 0570411, 0571613, 0573009, 0577882, 0581075, 0584965, 0587430, 0585731, 0585730, 0585732, 0598360, 0601970 and 0605113.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US, Indonesia, UAE, Hong Kong, Japan, Singapore, Malaysia, Taiwan, Belgium, Uraguay, Venezuela, Columbia, Mexico, Guam, Vietnam and Thailand.
  • Description du dispositif
    Sternal Saw II Sterile Blades for the Sarns Sternal Saw System, Catalog number 5589, Terumo Cardiovascular System Corp, Ann Arbor, MI. || The sternal saw blades are indicated for use in medial sternotomoties. The saw blades are used wit the Sarns Sternal Saw System.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Adresse du fabricant
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Source
    USFDA