BEUDAMED
    FDA Enforcement Class II Ongoing

    2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.

    Recall: Z-1702-2026 · Reported April 8, 2026

    Enforcement

    Recall Number
    Z-1702-2026
    Event ID
    98461
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2026
    Initiation Date
    February 25, 2026
    Classification Date
    March 30, 2026
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986, United States

    Description

    2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.

    Reason

    A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.

    Code Info

    Part Number: 03.424.124-US. GTIN: 10886982335944. Lot Number: 68900P9.

    Distribution

    US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI.

    Quantity

    77 units