Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
This recall has been terminated (originally issued December 22, 2015).
- Recall Initiated
- November 24, 2015
- Posted
- December 22, 2015
- Terminated
- June 27, 2016
- Recall Number
- Z-0469-2016
- Quantity
- 39 units
- Official Source
- View on FDA website ↗
Reason for Recall
The sterile blade will not fit into the handle provided with the ETTD system.
Distribution
US distribution to the states: TX, UT, NY and CO.
Lot / Code Info
Lot number MDHZ620
Root Cause
Employee error
Action Taken
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.