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U.S. Department of Health and Human Services

Class 2 Device Recall Guide Wire

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  Class 2 Device Recall Guide Wire see related information
Date Initiated by Firm February 17, 2017
Date Posted March 16, 2017
Recall Status1 Terminated 3 on May 19, 2017
Recall Number Z-1483-2017
Recall Event ID 76562
Product Classification Orthopedic manual surgical instrument - Product Code LXH
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.
Code Information .045 X 6 ST Guide Wire Lot number: 391681  .054 X 7 ST Guide Wire Lot number: 391680
Recalling Firm/
Manufacturer		 Acumed LLC
5885 NW Cornelius Pass Rd
Hillsboro OR 97124-9432
For Additional Information Contact Acumed Business Services
503-627-9957 Ext. 4
Manufacturer 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).
FDA Determined
Cause 2		 Process control
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 RecallNotification@acumed.net. Domestic customers with questions or need to return products to Acumed, please contact Acumed Agent Inventory via email AgentInventory@acumed.net 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 BusinessServices@acumed.net 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).
Quantity in Commerce 24 units of .045 X 6 ST Guide Wire and 25 units of .054 X 7 ST Guide Wire
Distribution Worldwide Distribution in Great Britain, Ireland, and Japan only.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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