BEUDAMED
    FDA Enforcement Class II 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 · Reported March 22, 2017

    Enforcement

    Recall Number
    Z-1483-2017
    Event ID
    76562
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Acumed LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2017
    Initiation Date
    February 17, 2017
    Classification Date
    March 16, 2017
    Termination Date
    May 19, 2017
    Address
    5885 NW Cornelius Pass Rd, N/A, Hillsboro, OR, 97124-9432, United States

    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).

    Code Info

    .045 X 6 ST Guide Wire Lot number: 391681 .054 X 7 ST Guide Wire Lot number: 391680

    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