Medical device recalls Moderate risk

MicroAire Surgical Instruments, LLC recalls MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device

Recall date
February 8, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1328-2016
FDA classification
Class II
Brand / firm
MicroAire Surgical Instruments, LLC
Sold / distributed
Worldwide Distribution - US Nationwide

Why it was recalled

MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery. Accordingly, the PAL-R4011XL has also been put on production hold until further notice.

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¿ Cannula Product Usage - Power Aspiration Device

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