Events

Rappel de Stryker Orthopaedics

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
    72498
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0362-2016
  • Date de mise en oeuvre de l'événement
    2015-09-21
  • Date de publication de l'événement
    2015-12-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141277
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Cause
    Stryker orthopaedics has received two customer complaints regarding duracon tibial wedge implants puncturing the packaging's tyvek lid(s).
  • Action
    On September 18, 2015, Stryker notified their Branches/Agencies of their action via email. The Branches/Agencies were instructed to quarantine affected devices. Urgent Medical Device Recall Notification Letters/Urgent Medical Device Recall Notification Acknowledgement Forms dated September 21, 2015 were sent to Branches/Agencies via UPS on 9/21/2015. Urgent Medical Device Recall Notification Letters/Urgent Medical Device Recall Notification Acknowledgement Forms dated September 21, 2015 were sent to Hospital Risk Managers via UPS on 9/23/2015. The notification instructed consignees on how to identify affected product; the related issue with the affected product; potential hazards; risk mitigations; and actions needed to be taken. Consignees were asked to contact their Stryker Orthopaedics Sales Representative to arrange for return of any recalled product. Customers were asked to complete and return the attached Product Recall Acknowledgement Form within 5 days and either email (strykerortho7984@stericycle.com or Fax (1-866-672-0627) the response form back. A point of contact was provided in case the customer had any questions 201.831.5826.

Device

Stryker Orthopaedics
  • Modèle / numéro de série
    Multiple Lot Numbers. Catalog Numbers: 6630-6-105, 6630-6-110, 6630-6-125, 6630-6-130, 6630-6-150, 6630-6-155, 6630-6-170, 6630-6-175, 6630-6-205, 6630-6-210, 6630-6-225, 6630-6-230, 6630-6-250, 6630-6-255, 6630-6-270, 6630-6-275, 6630-6-305, 6630-6-310, 6630-6-325, 6630-6-330, 6630-6-350, 6630-6-355, 6630-6-370, 6630-6-375, 6630-6-405, 6630-6-410, 6630-6-425, 6630-6-430, 6630-6-450, 6630-6-455, 6630-6-470 and 6630-6-475.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed US (nationwide) and the countries of Australia, Canada, Germany, Hong Kong, Italy, Japan, Malaysia, New Zealand, Netherlands, Poland, Romania, Spain, Sweden and Switzerland.
  • Description du dispositif
    Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended to be used with the Universal tibial baseplate to augment bone loss on the surface of the tibia.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA