BEUDAMED
    FDA Enforcement Class II Terminated

    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002

    Recall: Z-1871-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1871-2018
    Event ID
    79791
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kelyniam Global, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 23, 2018
    Initiation Date
    June 10, 2017
    Classification Date
    May 14, 2018
    Termination Date
    September 14, 2020
    Address
    97 River Rd, Collinsville, CT, 06019-3246, United States

    Description

    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002

    Reason

    Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to FDA for marketing clearance. The Temporal Suture System (TSS) is no longer being offered and the Integrated Fixation System (IFS) has been temporarily suspended

    Code Info

    Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C. Case Numbers: CSI082114-CT1 CSI081214-TB1 CSI020216-LK1 CSI092016-LD1R CSI100116-BM1A CSI092616-YB1 CSI092616-MM1 CSI112316-YB1 CSI050217-LS1 CSI052217-AF1 CSI062317-GM1 CSI071017-NS1B CSI071417-CM1 CSI102617-DL1 CSI101617-JF1A CSI102617-DL1

    Distribution

    US nationwide distribution.

    Quantity

    16