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Terminated

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

FDA Recall Z-0469-2016 · Posted 2015-12-22

Recalling FirmInstratek, Incorporated
Recall StatusTerminated
Product CodeHRX
Date Initiated2015-11-24
Date Terminated2016-06-27
Product Quantity39 units

Reason for Recall

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

Firm 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.

Root Cause

Employee error

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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