BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    Recall: Z-2382-2020 · Reported June 24, 2020

    Enforcement

    Recall Number
    Z-2382-2020
    Event ID
    85681
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2020
    Initiation Date
    May 7, 2020
    Classification Date
    June 16, 2020
    Termination Date
    September 21, 2023
    Address
    Bohnackerweg 1, Selzach, N/A, Switzerland

    Description

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    Reason

    Seal integrity of the blister pack may be compromised and sterility cannot be assured

    Code Info

    Lot Number: K02AE3F, K02C191, K02C1AA, K0302F9, K0302FA, K0302FD, K030307, K030313, K030315, K030EE3, K030EE4, K030EE5, K030EE8, K031B63, K032879, K0E902D, K0E9086, K0E90B7, K0E90BB, K0EAC03

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.

    Quantity

    OUS: 1404