CLASS II Device recall · Reported 22 Mar 2017 · FDA Enforcement Report
ST Guide Wire recalled by Acumed
Acumed is recalling ST Guide Wire. The recall was initiated on 17 Feb 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1483-2017
- FDA event ID
- 76562
- Recalling firm
- Acumed, Hillsboro, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Feb 2017
- FDA classified
- 16 Mar 2017
- Reported
- 22 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 17 Feb 2017 | Recall initiated by company | |
| 16 Mar 2017 | Classified by FDA | +27 days |
| 22 Mar 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
.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.
Where it was distributed
Worldwide Distribution in Great Britain, Ireland, and Japan only.
Questions about this recall
Is ST Guide Wire recalled?
Yes. Acumed recalled ST Guide Wire on 17 Feb 2017. The recall is Class II and its status is Terminated. Recall number Z-1483-2017.
Why was it recalled?
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).
Which lots are affected?
.045 X 6 ST Guide Wire Lot number: 391681 .054 X 7 ST Guide Wire Lot number: 391680
Where was it sold?
Worldwide Distribution in Great Britain, Ireland, and Japan only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Acumed
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hexalob Screw various sizes recalled by Acumed | Acumed | Device Malfunction | Nationwide |
| Device | CLASS II | RibLoc U Plus 90 Instrument Primary Guide Assy, Low Profile recalled | Acumed | Device Malfunction | Nationwide |
| Device | CLASS II | AcuTwist Acutrak Compression Screws recalled by Acumed | Acumed | Other | Nationwide |
| Device | CLASS II | Dual-Trak Clavicle Screws recalled by Acumed | Acumed | Other | Nationwide |
| Device | CLASS II | Cannulated Screw, Short Thread recalled by Acumed | Acumed | Foreign Material | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |