Medical device recalls Moderate risk

Instratek, Incorporated recalls Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ET…

Recall date
November 24, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0469-2016
FDA classification
Class II
Brand / firm
Instratek, Incorporated
Sold / distributed
US distribution to the states: TX, UT, NY and CO.

Why it was recalled

The sterile blade will not fit into the handle provided with the ETTD system.

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

What was recalled

Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.

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