BEUDAMED
    FDA Enforcement Class II Terminated

    6376 M-1 Cot Fastener, catalog no. 6376000000

    Recall: Z-1598-2018 · Reported May 9, 2018

    Enforcement

    Recall Number
    Z-1598-2018
    Event ID
    79817
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Medical Division of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    May 9, 2018
    Initiation Date
    March 9, 2018
    Classification Date
    May 2, 2018
    Termination Date
    April 9, 2019
    Address
    3800 E Centre Ave, N/A, Portage, MI, 49002-5826, United States

    Description

    6376 M-1 Cot Fastener, catalog no. 6376000000

    Reason

    The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.

    Code Info

    Serial No. 170740300 170740301 170740302 170740303 170740304 170740305 170740306 170740307 170740308 170740309 170740310 170740311 170740312 170740313 170740314 170740315 170740316 170740317 170740318 170740319 170740320 170740321 170740322 170740323 170740324 170740325 170740326 170740327 170740328 170740329 170740330 170740331 170740332 170740333 170740334 170740335 170740336 170740337 170740338 170740339 170740340 170740341 170740342 170740343 170740344 170740345 170740346 170740347 170740348 170740349 170740350 170740351 170740352 170740353 170740354 170740355 170740356 170740357 170740358

    Distribution

    Product distributed to the Netherlands

    Quantity

    59