BEUDAMED
    FDA Enforcement Class II Terminated

    NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.

    Recall: Z-0250-2016 · Reported November 18, 2015

    Enforcement

    Recall Number
    Z-0250-2016
    Event ID
    72500
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ceterix Orthopedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    November 18, 2015
    Initiation Date
    October 13, 2015
    Classification Date
    November 9, 2015
    Termination Date
    February 12, 2016
    Address
    959 Hamilton Ave, N/A, Menlo Park, CA, 94025-1431, United States

    Description

    NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.

    Reason

    The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.

    Code Info

    Ceterix catalog number CTX-001; Lot numbers: M150016 M150056 M150078 M150105 M150136 M150182 M150185 M150202 M150207 M150225 M150239.

    Distribution

    Nationwide Distribution

    Quantity

    1364 units