Z-0469-2016 Class II Terminated
FDA device recall Z-0469-2016 was initiated by Instratek, Incorporated on November 24, 2015 and is designated Class II. Reason for recall: The sterile blade will not fit into the handle provided with the ETTD system. The recall status is terminated (terminated June 27, 2016). Affected quantity: 39 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2015
- Initiation Date
- November 24, 2015
- Termination Date
- June 27, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39 units
Product Description
Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
Reason for Recall
The sterile blade will not fit into the handle provided with the ETTD system.
Distribution Pattern
US distribution to the states: TX, UT, NY and CO.
Code Information
Lot number MDHZ620