Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
Recall
- Recall Number
- Z-0469-2016
- Event Number
- 72748
- Firm
- Instratek, Incorporated 15200 Middlebrook Dr Ste G Houston TX 77058-1217
- FEI Number
- 1000118334
- Product Code
- HRX
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- November 24, 2015
- Posted
- December 22, 2015
- Terminated
- June 27, 2016
Description
Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
The sterile blade will not fit into the handle provided with the ETTD system.
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.
US distribution to the states: TX, UT, NY and CO.
39 units