Events

Rappel de Device Recall STERIS Fine Traction Device

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 Steris 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
    65573
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1786-2013
  • Date de mise en oeuvre de l'événement
    2013-05-20
  • Date de publication de l'événement
    2013-07-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119612
  • 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
    Apparatus, traction, non-powered - Product Code HST
  • Cause
    A bearing used in the assembly of the fine traction device did not perform successfully in pre-release reliability testing; a replacement bushing passed reliability testing and was substituted per a change order. the change order authorized use of the substitute bushing in assembly of the fine traction accessory; however, inadvertently the new part was not implemented. during complaint evaluati.
  • Action
    STERIS Account Managers notified affected customers via onsite visits. All consignees were notified as of 5/29/2013. Customers were instructed to return affected product for a replacement unit.

Device

Device Recall STERIS Fine Traction Device
  • Modèle / numéro de série
    The following serial/lot numbers are affected by this recall:  0404913150, 0404913151, 0404913152, 0404913153, 0408713001, 0408713002, 0408713003, 0408713004, 0408713005, 0408713006, 0409813097, 0409813098, 0409813099, 0409813100, 0410113001, 0410113002, 0410713024, 0410713025, 0410713026, 0410713027, 0410713028, and 0410713029.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada.
  • Description du dispositif
    STERIS Fine Traction Device, one unit per box || Product Usage: || The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Adresse du fabricant
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Société-mère du fabricant (2017)
    Steris Corporation
  • Source
    USFDA