Acumed LLC recalls .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 diam…

Recall date

February 17, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1483-2017

FDA classification

Class II

Brand / firm

Acumed LLC

Sold / distributed

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

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

.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.