BEUDAMED
    FDA Recall Terminated

    .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument.

    Recall: Z-1483-2017 · Initiated February 17, 2017

    Recall

    Recall Number
    Z-1483-2017
    Event Number
    76562
    Firm
    Acumed LLC
    FEI Number
    1000125930
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 17, 2017
    Posted
    March 16, 2017
    Terminated
    May 19, 2017
    Address
    5885 NW Cornelius Pass Rd, Hillsboro, OR, 97124-9432

    Description

    .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument.

    Reason

    Guide wires sized as .045 X 6 were mis-packaged as .054 X 7 guide wires and those sized as .054 X 7 were mis- packaged as .045 X 6 guide wires. There is a possibility that using the incorrect guide wire size can cause health hazards, such as mal or nonunion, need for revision surgery, and histological response (if wire breaks).

    Action

    Acumed sent an Urgent Medical Device Recall letter dated 02/16/2017, to all affected customers on 02/17/2017. Consignees were instructed to follow special instructions and send survey to [email protected]. Domestic customers with questions or need to return products to Acumed, please contact Acumed Agent Inventory via email [email protected] to obtain a Return Material Authorization (RMA) number or contact your agent directly. International customers with questions or need to return products to Acumed, please contact Acumed Business Service via email at [email protected] or call to obtain a Return Material Authorization (RMA) number. Customers with questions about recall can call 877-627-9957, choose Option 4 (US and Canada), or call 001-503-627-9957, choose option 4 (outside of US and Canada).

    Distribution

    Worldwide Distribution in Great Britain, Ireland, and Japan only.

    Quantity

    24 units of .045 X 6 ST Guide Wire and 25 units of .054 X 7 ST Guide Wire