BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated February 15, 2023

    Recall

    Recall Number
    Z-2098-2023
    Event Number
    92493
    Firm
    Pro-Dex Inc
    FEI Number
    2081135
    Product Code
    GEY
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    February 15, 2023
    Posted
    July 5, 2023
    Address
    2361 McGaw Ave, Irvine, CA, 92614-5831

    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.

    Action

    On 2/15/23, a recall notice was sent to a customer asking them to cease distribution and return affected product to the recalling firm. Questions can be directed to 949-769-3200.

    Distribution

    US: FL

    Quantity

    2000