Acumed LLC: Medical Device Recall in 2017 - (Recall #: Z-1483-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: February 17, 2017

Date Posted: March 22, 2017

Recall Number: Z-1483-2017

Event ID: 76562

Reason for Recall:

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).

Status: Terminated

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

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated