Instratek, Incorporated: Medical Device Recall in 2015 - (Recall #: Z-0469-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: November 24, 2015
Date Posted: December 30, 2015
Recall Number: Z-0469-2016
Event ID: 72748
Reason for Recall:

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

Status: Terminated
Product Quantity: 39 units
Code Information:

Lot number MDHZ620

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated