FDA Medical Device Recalls (openFDA)
Acumed LLC: .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.
- Recall number
- Z-1483-2017
- Recalling firm
- Acumed LLC
- 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.
- Status
- Terminated
- Initiated
- 2017-02-17
- Posted
- 2017-03-16
- Terminated
- 2017-05-19
- 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).
- Root cause
- 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
- 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.
- Lot, serial or model codes
- .045 X 6 ST Guide Wire Lot number: 391681 .054 X 7 ST Guide Wire Lot number: 391680
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1000125930
- Firm city
- Hillsboro
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28