BEUDAMED
    FDA Recall Open, Classified

    2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.

    Recall: Z-1703-2026 · Initiated February 25, 2026

    Recall

    Recall Number
    Z-1703-2026
    Event Number
    98461
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    HWX
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    February 25, 2026
    Posted
    March 30, 2026
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-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.

    Action

    Depuy Synthes initially notified Sales Consultants and Regional Managers on about 02/25/2026, followed by notification of consignees. Consignees were instructed to examine inventory for affected units, quarantine them immediately, and contact Depuy Synthes sales consultant or customer support services to arrange the return/credits for affected units. Additionally, consignees were requested to complete and return the provided Business Response Form as well as notify all applicable personnel within the facility or any consignees if the affected units were further distributed. Consignees were also requested to post the notification in a visible area for awareness.

    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

    33 units