FDA-Device2017-03-15Class II

MicroAire K-Wires

MicroAire Surgical Instruments, LLC
Hazard

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).

Sold states
United States.
Affected count
Total 362
Manufactured in
3590 Grand Forks Blvd, N/A, Charlottesville, VA, United States
Products
MicroAire K-Wires

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1407-2017

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