BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0114-2016 · Reported October 14, 2015

    Enforcement

    Recall Number
    Z-0114-2016
    Event ID
    72170
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Craniomaxillofacial Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 14, 2015
    Initiation Date
    September 17, 2015
    Classification Date
    October 8, 2015
    Termination Date
    February 26, 2016
    Address
    750 Trade Centre Way, Ste 200, Portage, MI, 49002-0482, United States

    Description

    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.

    Reason

    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.

    Code Info

    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)

    Distribution

    Worldwide distribution -- US, Canada, France, Germany, Italy, Japan, Norway, Sweden, Switzerland, and the Netherlands.

    Quantity

    915 packs