Z-1483-2017 Class II Terminated
FDA device recall Z-1483-2017 was initiated by Acumed LLC on February 17, 2017 and is designated Class II. 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 w… The recall status is terminated (terminated May 19, 2017). Affected quantity: 24 units of .045 X 6 ST Guide Wire and 25 units of .054 X 7 ST Guide Wire.
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2017
- Initiation Date
- February 17, 2017
- Termination Date
- May 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units of .045 X 6 ST Guide Wire and 25 units of .054 X 7 ST Guide Wire
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.
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).
Distribution Pattern
Worldwide Distribution in Great Britain, Ireland, and Japan only.
Code Information
.045 X 6 ST Guide Wire Lot number: 391681 .054 X 7 ST Guide Wire Lot number: 391680