FDA-Device2017-03-22Class II
.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.
Acumed LLC
Hazard
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).
Sold states
Worldwide Distribution in Great Britain, Ireland, and Japan only.
Affected count
24 units of .045 X 6 ST Guide Wire and 25 units of .054 X 7 ST Guide Wire
Manufactured in
5885 NW Cornelius Pass Rd, N/A, Hillsboro, OR, United States
Products
.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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1483-2017Don't want to check this manually?
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