BEUDAMED
    FDA Enforcement Class II Terminated

    PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.

    Recall: Z-2340-2019 · Reported August 28, 2019

    Enforcement

    Recall Number
    Z-2340-2019
    Event ID
    83113
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pro-Dex Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2019
    Initiation Date
    September 25, 2018
    Classification Date
    August 22, 2019
    Termination Date
    April 20, 2022
    Address
    2361 McGaw Ave, N/A, Irvine, CA, 92614-5831, United States

    Description

    PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.

    Reason

    Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.

    Code Info

    PDBP-001 Series Model: PDBP-040-2 (40ct PDBP-001-2) which are 40 count batteries. Lot(s): K098N (61900), K0B3F (62625) K098N and K0B3F are Pro-Dex lot numbers. 61900 and 62625 are the contract packager's lot numbers UDI Code: (01) 0 0860540 00025 6

    Distribution

    Worldwide distribution - US Nationwide distributed in the states of CA, FL, MI, and TX, country of Finland.

    Quantity

    68 cases of 40 batteries = 2,720 individual batteries