BEUDAMED
    FDA Enforcement Class II Ongoing

    KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver

    Recall: Z-2098-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2098-2023
    Event ID
    92493
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Pro-Dex Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 12, 2023
    Initiation Date
    February 15, 2023
    Classification Date
    July 5, 2023
    Address
    2361 McGaw Ave, N/A, Irvine, CA, 92614-5831, United States

    Description

    KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver

    Reason

    Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired.

    Code Info

    REF: KLS-BP-001/KLS-BP-040, UDI-DI: 00862377000140, Lot: K0M6U, Expiration: 8/31/2024

    Distribution

    US: FL

    Quantity

    2000