BEUDAMED
    FDA Enforcement Class II Ongoing

    KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000

    Recall: Z-0280-2025 · Reported November 6, 2024

    Enforcement

    Recall Number
    Z-0280-2025
    Event ID
    95510
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Pro-Dex Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2024
    Initiation Date
    September 23, 2024
    Classification Date
    October 31, 2024
    Address
    2361 McGaw Ave, N/A, Irvine, CA, 92614-5831, United States

    Description

    KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000

    Reason

    The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.

    Code Info

    Lot: REF/UDI-DI: K0UB9: KLS-BP2-001/00856482008122, KLS-BP2-040/10856482008129. KLS-SD-2000/00856482008115

    Distribution

    US distribution to FL only.

    Quantity

    2000