BEUDAMED
    FDA Recall Terminated

    Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO

    Recall: Z-1373-2018 · Initiated January 11, 2018

    Recall

    Recall Number
    Z-1373-2018
    Event Number
    79224
    Firm
    TriMed Inc.
    FEI Number
    3001236812
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 11, 2018
    Terminated
    January 18, 2024
    Address
    27533 Avenue Hopkins, Santa Clarita, CA, 91355-3910

    Description

    Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO

    Reason

    Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy.

    Action

    Recall notification letters were sent to affected consignees on January 16, 2018. The consignee letter requests that the consignee return an initial Acknowledgement & Receipt Form to TriMed by January 23, 2018.

    Distribution

    US, China, Latin America

    Quantity

    1525 devices