Events

Rappel de Disposable Paper Filter for Containers

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 Craniomaxillofacial Division.

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
    72170
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0114-2016
  • Date de mise en oeuvre de l'événement
    2015-09-17
  • Date de publication de l'événement
    2015-10-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-02-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140151
  • 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
    Tray, surgical, instrument - Product Code FSM
  • Cause
    Stryker has become aware that the inhomogeneity of the filter paper might potentially compromise the ability of the filter to maintain a sterile barrier during post-sterilization shelf-life.
  • Action
    An Urgent Medical Device Recall letter has been sent to the customers. The affected product was identified, as well as the reason for the recall and risk to health. The letter states that customers should inform users of the Medical Device Removal and pass the notice to all appropriate individuals within the organization; scrap all affected products available at the location or return it to Stryker Craniomaxillofacial, Attention: Recall Coordinator, at the address provided. If there are questions regarding the impacted product, don't hesitate to Contact Stryker Customer service and refer to PFA #2015-032. Complete and sign the enclosed Business Reply Form and fax or copy to: (877) 648-7114 or e-mail a copy to CMF-custserv@stryker.com.

Device

Disposable Paper Filter for Containers
  • Modèle / numéro de série
    Part Number:  29-10911 Disposable Paper Filter for Sterilization Container, 30x29cm, new type (P/100);  29-10912 Disposable Paper Filter for Sterilization Container, 60x 29cm, old type (P/100), obsolete (Part not distributed in the US);  29-10913 Dispoable Paper Filter for Sterilization Container, 60x29cm new type (P/100) (Part not distributed in the US);  29-10915 Disposable Paper Filter, 4-holes, for Coiner (Part not distributed in the US)
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution -- US, Canada, France, Germany, Italy, Japan, Norway, Sweden, Switzerland, and the Netherlands.
  • Description du dispositif
    Disposable Paper Filter for Sterilization Containers || Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured and distributed by Stryker Leibinger GmbH & Co KG, Distributed in the USA by: Stryker Orthopedics, NON STERILE.
  • Manufacturer
    Stryker Craniomaxillofacial Division

Manufacturer

Stryker Craniomaxillofacial Division
  • Adresse du fabricant
    Stryker Craniomaxillofacial Division, 750 Trade Centre Way, Ste 200, Portage MI 49002-0482
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA