BEUDAMED
    FDA Enforcement Class II Terminated

    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)

    Recall: Z-1870-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1870-2018
    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-IM1001 (Small)

    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: CSI041216-CM1 CSI092016-LD1L

    Distribution

    US nationwide distribution.

    Quantity

    2