MicroAire Surgical Instruments, LLC recalls MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula

Recall date

February 8, 2016

Source

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

Recall number

Z-1323-2016

FDA classification

Class II

Brand / firm

MicroAire Surgical Instruments, LLC

Sold / distributed

Worldwide Distribution. US nationwide including Puerto Rico, Australia, Bangladesh, Czech Republic, India, Japan, Lebanon, New Zealand, Norway, Singapore, Switzerland, Taiwan, and Turkey.

Why it was recalled

Complaints that the cannula bent/broke during surgery.

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 PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula