BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated September 23, 2024

    Recall

    Recall Number
    Z-0280-2025
    Event Number
    95510
    Firm
    Pro-Dex Inc
    FEI Number
    2081135
    Product Code
    MOQ
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    September 23, 2024
    Posted
    October 31, 2024
    Address
    2361 McGaw Ave, Irvine, CA, 92614-5831

    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.

    Action

    On 9/23/24, an "URGENT" recall notice was emailed to the customer informing of the product, issue, risk and actions to be taken. Customers were instructed to do the following: 1) Please immediately cease distribution and use of these lots. Inventory and distribution records should be evaluated to ensure that affected product is removed from any potential point of use. 2) Product should be returned to the recalling firm. 3) The Recall Acknowledgement and Return Form should be completed and returned via email to [email protected] or FAX 949.769.3281. Questions or concerns can be directed to the firm at 949-769-3200 or [email protected]

    Distribution

    US distribution to FL only.

    Quantity

    2000