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Terminated

.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.

FDA Recall Z-1483-2017 · Posted 2017-03-16

Recalling FirmAcumed LLC
Recall StatusTerminated
Product CodeLXH
Date Initiated2017-02-17
Date Terminated2017-05-19
Product Quantity24 units of .045 X 6 ST Guide Wire and 25 units of .054 X 7 ST Guide Wire

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).

Firm Action

Acumed sent an Urgent Medical Device Recall letter dated 02/16/2017, to all affected customers on 02/17/2017. Consignees were instructed to follow special instructions and send survey to [email protected]. Domestic customers with questions or need to return products to Acumed, please contact Acumed Agent Inventory via email [email protected] to obtain a Return Material Authorization (RMA) number or contact your agent directly. International customers with questions or need to return products to Acumed, please contact Acumed Business Service via email at [email protected] or call to obtain a Return Material Authorization (RMA) number. Customers with questions about recall can call 877-627-9957, choose Option 4 (US and Canada), or call 001-503-627-9957, choose option 4 (outside of US and Canada).

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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