BEUDAMED
    FDA Enforcement Class II Terminated

    2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

    Recall: Z-0902-2018 · Reported March 14, 2018

    Enforcement

    Recall Number
    Z-0902-2018
    Event ID
    79157
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 14, 2018
    Initiation Date
    July 26, 2017
    Classification Date
    March 5, 2018
    Termination Date
    September 10, 2018
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

    Reason

    Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

    Code Info

    Distributed 17-Apr-2017 to 8-June-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H040501 7/29/2016 2025-06-30 H105498 8/5/2016 2026-02-28 H213824 10/27/2016 2025-09-30

    Distribution

    Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and country of: Canada.

    Quantity

    216