BEUDAMED
    FDA Enforcement Class II Ongoing

    Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;

    Recall: Z-1621-2025 · Reported April 23, 2025

    Enforcement

    Recall Number
    Z-1621-2025
    Event ID
    96555
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 23, 2025
    Initiation Date
    March 28, 2025
    Classification Date
    April 17, 2025
    Address
    Bohnackerweg 1, Selzach, N/A, Switzerland

    Description

    Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;

    Reason

    The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.

    Code Info

    Catalog number/REF: 2351-3100S; UDI-DI: 07613327361803; Lot #: KU164143, KU164755, KU164756, KU164757, KU164758, KU164759, KU164760, KU164761, KU164762, KU164763, KU164764, KU164765, KU164766, KU164767, KU164768, KU164769, KU164770, KU164771, KU164772, KU164773, KU164774, KU164775, KU164776, KU164777, KU164778, KU164779, KU164780, KU164781, KU164782, KU164783, KU164784, KU165161, KU165162, KU165163, KU165164, KU165165, KU165166, KU165167, KU165168, KU165169, KU165170, KU165171, KU165172, KU165173, KU165174, KU165175, KU184035, KU184036, KU184039, KU184041, KU184042, KU184044, KU184045, KU184046, KU184047, KU184049.

    Distribution

    US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.

    Quantity

    6407 units