Z-1483-2017Class II

.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...

Name: Z-1483-2017 .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...
Creator: Acumed LLC
Published: 2017-02-17
License: https://open.fda.gov/license/

Acumed LLC / initiated 2017-02-17 / Terminated / root cause: manufacturing process

FDA source

Acumed LLC began a recall of .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... on 2017-02-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1483-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-17
Posted: 2017-03-16
Terminated: 2017-05-19
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.
Product code: LXH 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).
Root cause tag: manufacturing process
FDA 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 [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).
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.
Product codes and lots: .045 X 6 ST Guide Wire Lot number: 391681 .054 X 7 ST Guide Wire Lot number: 391680

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1483-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1483-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-16

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)