Events

Rappel de Device Recall Femoral sponge.

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
    54622
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1105-2010
  • Date de mise en oeuvre de l'événement
    2010-01-25
  • Date de publication de l'événement
    2010-03-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-10-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88799
  • 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
    Gauze/sponge, internal, x-ray detectable - Product Code GDY
  • Cause
    The firm did not have packaging validation to support the labeled shelf life. there is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product.
  • Action
    A "Medical Device Recall Notification" dated January 21, 2010 was issued to customers. The notification described the affected product, issue and actions to take. Consignees were asked to forward the notification to all their affected locations. Customers were instructed to immediately check inventory and quarantine any recalled product found. Consignees were instructed to destroy all product and report how much product was destroyed. For questions regarding this recall, please contact Stryker Instruments by calling 1-800-800-4236, ext. 4354

Device

Device Recall Femoral sponge.
  • Modèle / numéro de série
    04230CE2, 04257CE2, 04286CE2, 04310CE2, 04334CE2, 05004CE2, 05041CE2, 05109CE2, 05200012, 05222012, 05292012, 05346012, 06038012, 06128012, 06172012, 06241012, 06268012, 06313012, 06348012, 07022012, 07031012, 07053012, 07081012, 07106012, 07136012, 07177012, 07192012, 07219012, 07253012, 07276012, 07320012, 07341012, 08010012, 08043012, 08063012, 08095012, 08127012, 08162012, 08177012, 08203012, 08249012, 08296012, 08325012, 08351012, 09040012, 09075012, 09106012 and 09138012.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States, Canada, Mexico, Australia, Brazil, Switzerland, Japan, Netherlands, England, UK, Sweden, Hong Kong, Korea, Malaysia, Singapore, Argentina, Spain, and Italy.
  • Description du dispositif
    Bio-Prep Bone Preparation Kit with Merocel sponge for use in total hip arthroplasty. REF 206-730, Rx, Sterile, Stryker Instruments Kalamazoo, MI. || The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction.
  • 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., Kalamazoo MI 49001
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA