CLASS II Device recall · Reported 15 Mar 2017 · FDA Enforcement Report
MicroAire K-Wires recalled by MicroAire Surgical Instruments
MicroAire Surgical Instruments is recalling MicroAire K-Wires. The recall was initiated on 21 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-1407-2017
- FDA event ID
- 76560
- Recalling firm
- MicroAire Surgical Instruments, Charlottesville, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Feb 2017
- FDA classified
- 3 Mar 2017
- Reported
- 15 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 21 Feb 2017 | Recall initiated by company | |
| 3 Mar 2017 | Classified by FDA | +10 days |
| 15 Mar 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of "single trocar" was on the product label on the following parts: 1600-9355NS (lot 61005), 1600-9625NS (lot 60297), and 1604-162NS (lot 62856).
Product as listed by the FDA
MicroAire K-Wires
Where it was distributed
United States.
Questions about this recall
Why was it recalled?
Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of "single trocar" was on the product label on the following parts: 1600-9355NS (lot 61005), 1600-9625NS (lot 60297), and 1604-162NS (lot 62856).
Which lots are affected?
Part Number, Lot Number, Quantity Distributed to Field 1600-9355NS, 61005, 56; 1600-9625NS, 60297, 209; 1604-162NS, 62856, 97.
Where was it sold?
United States.
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 26 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 MicroAire Surgical Instruments
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SmartRelease Onyx recalled by MicroAire Surgical Instruments | MicroAire Surgical Instruments | Other | Nationwide |
| Device | CLASS II | SmartRelease Endoscopic Carpal Tunnel Release Handpiece recalled | MicroAire Surgical Instruments | Other | 26 states |
| Device | CLASS II | MicroAire SmartRelease Endoscopic System recalled | MicroAire Surgical Instruments | Sterility | Nationwide |
| Device | CLASS II | Sst Twist Drill, Standard Dia recalled by MicroAire Surgical Instruments | MicroAire Surgical Instruments | Other | VA |
| Device | CLASS II | Endotine Transbleph 3.5 (CFD-080-0167) recalled | MicroAire Surgical Instruments | Labeling Errors | VA |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |