Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

.045 X 6 ST Guide Wire Recalled by Acumed LLC Due to Guide wires sized as .045 X 6 were...

Date: February 17, 2017
Company: Acumed LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Acumed LLC directly.

Affected 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.

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

Why Was This 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).

Where Was This Sold?

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

About Acumed LLC

Acumed LLC has 14 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report