Reported Dec 30, 2015 · Terminated

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

Instratek, Incorporated

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Instratek, Incorporated · 15200 Middlebrook Dr Ste G · Houston, TX · 77058-1217

Is this the product you have?

  • Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
Lot codes and dates
  • Lot number MDHZ620
Amount recalled
39 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 27, 2016 · Data as of Sep 19, 6:01 PM UTC

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