Nico Corp. recalls Myriad handpiece Tissue morcellator

Recall date

February 24, 2014

Source

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

Recall number

Z-2045-2016

FDA classification

Class II

Brand / firm

Nico Corp.

Sold / distributed

US Distribution to the states of : OR, IL, IA, NC, TX, CA, GA, OH, WI, AR, MI, MD, IN.

Why it was recalled

This recall has been initiated due to a defective component within the handpiece which will cause the handpiece to fail. The failure will result in the inability to cut tissue with the handpiece, rendering it non-functional. Should this failure occur, a replacement Myriad handpiece will be required. If a replacement handpiece is not available, alternate instrumentation for tissue removal will be necessary.

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

What was recalled

Myriad handpiece Tissue morcellator