Reported Mar 15, 2017 · Terminated

MicroAire K-Wires

MicroAire Surgical Instruments, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MicroAire Surgical Instruments, LLC · 3590 Grand Forks Blvd · Charlottesville, VA · 22911-9006

Is this the product you have?

  • MicroAire K-Wires
Lot codes and dates
    • Part Number
    • Lot Number
    • Quantity Distributed to Field 1600-9355NS
    • 61005
    • 56
    • 1600-9625NS
    • 60297
    • 209
    • 1604-162NS
    • 62856
    • 97
Amount recalled
Total 362

Why it was 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).

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 14, 2017 · Data as of Sep 19, 6:06 PM UTC

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