Z-0469-2016Class II

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

Name: Z-0469-2016 Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel...
Creator: Instratek, Incorporated
Published: 2015-11-24
License: https://open.fda.gov/license/

Instratek, Incorporated / initiated 2015-11-24 / Terminated / root cause: manufacturing process

FDA source

Instratek, Incorporated began a recall of Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System on 2015-11-24. FDA classified it as Class II and gives the reason as "The sterile blade will not fit into the handle provided with the ETTD system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0469-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-24
Posted: 2015-12-22
Terminated: 2016-06-27
Recalling firm: Instratek, Incorporated
Product: Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
Product code: HRX Arthroscope
Reason for recall: The sterile blade will not fit into the handle provided with the ETTD system.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Instratek contacted customers by phone call either by direct contact or voice mail message on November 23, 2015. that a recall was being initiated. Formal letters were sent via UPS to the Customers annoucing the recall on November 24, 2015. Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product,please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. You should contact lnstratek's Customer service for a return authorization number and further instructions for return of unused product.
Quantity in commerce: 39 units
Distribution: US distribution to the states: TX, UT, NY and CO.
Product codes and lots: Lot number MDHZ620

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0469-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0469-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-22

Product code HRX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)