BEUDAMED
    FDA Enforcement Class II Ongoing

    Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35

    Recall: Z-2192-2025 · Reported August 6, 2025

    Enforcement

    Recall Number
    Z-2192-2025
    Event ID
    97089
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Phasor Health, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 6, 2025
    Initiation Date
    March 21, 2025
    Classification Date
    July 29, 2025
    Address
    8944 Kirby Dr, Houston, TX, 77054-2829, United States

    Description

    Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35

    Reason

    Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.

    Code Info

    UDI-DI: B775270S0, B775320L0, B7754500, B7755300, B7756350. Lot: 241002450, 241002530, 241009450, 241009530, 241016450, 241016530, 241023450, 241023530, 241030450, 241030530, 24112027S, 24121827S, 24122727S, 25012227S, 24082832L, 24102332L, 241227450, 241220635, 250122635, 241227530, 250122530.

    Distribution

    US: PA, IN, AZ, MO, LA, FL, TX, MA, OH, TN, MI, WV, VA, CA, DE, NH, GA, SC, GU, NY, NJ, MN, WI, NE, WA, IL, AR, PR, VT

    Quantity

    1,064