Device product
.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.
Z-1483-2017
Product summary
- Firm
- Acumed LLC
- Event
- Event 76562
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 units of .045 X 6 ST Guide Wire and 25 units of .054 X 7 ST Guide Wire
- Official record key
device-enforcement:Z-1483-2017
Official wording
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 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.
Derived failure modes
-
Unknown
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).