BEUDAMED
    FDA Recall Terminated

    NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected when placing the bone pins.

    Recall: Z-1634-2020 · Initiated February 27, 2020

    Recall

    Recall Number
    Z-1634-2020
    Event Number
    85110
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 27, 2020
    Terminated
    August 2, 2024
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected when placing the bone pins.

    Reason

    Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.

    Action

    The firm, Smith & Nephew, notified customers on about 03/03/2020 via "Urgent Medical Device Recall Notice" letter. The customers were Instructed to examine inventory and quarantine affected devices, notify customers if further distributed, and complete and return the Response Form to [email protected] or fax to 1-901-566-7975. Questions and concerns can be directed to EieldActions@smlth-nephew .com. or 901-399-1970.

    Distribution

    Nationwide distribution to AL, AZ, CA, CT, FL, GA, HI, IA, IL, KS, LA, MA, MI, MN, MS, MT, NC, NJ, NY, OH, OK, PA, TN, TX, VA, WA, WI, WV. International distribution to Turkey, United Kingdom, Thailand, Switzerland, France, Australia.

    Quantity

    348 units