Z-0469-2016 Class II Terminated

Recalled by Instratek, Incorporated — Houston, TX

Recall Details

Product Type
Devices
Report Date
December 30, 2015
Initiation Date
November 24, 2015
Termination Date
June 27, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
39 units

Product Description

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

Reason for Recall

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

Distribution Pattern

US distribution to the states: TX, UT, NY and CO.

Code Information

Lot number MDHZ620