MicroAire K-Wires recalled over labeling errors

Recall date

February 21, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

MicroAire Surgical Instruments, LLC recalls MicroAire K-Wires

Recall number

Z-1407-2017

FDA classification

Class II

Brand / firm

MicroAire Surgical Instruments, LLC

Sold / distributed

United States.

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MicroAire K-Wires