BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0250-2016 · Initiated October 13, 2015

    Recall

    Recall Number
    Z-0250-2016
    Event Number
    72500
    Firm
    Ceterix Orthopedics, Inc.
    FEI Number
    3009131204
    Product Code
    NBH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 13, 2015
    Posted
    November 9, 2015
    Terminated
    February 12, 2016
    Address
    959 Hamilton Ave, Menlo Park, CA, 94025-1431

    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.

    Action

    Ceterix Orthopaedics sent an Urgent Field Safety notification letter dated October 13, 2015, to all affected sites. The product was identified, reason for recall explained and letter contains list of product lot numbers affected. Customers were instructed to identify and quarantine the affected product, contact Ceterix Orthopaedics to arrange a no cost return, and complete and return the attached acknowledgement form. Customers with questions were instructed to call 1-888-305-0615 or email: [email protected]. For questions regarding this recall call 650-396-3478.

    Distribution

    Nationwide Distribution

    Quantity

    1364 units