Recall Z-0469-2016— Instratek, Incorporated
Class II · Terminated
Class II FDA medical device recall by Instratek, Incorporated, initiated 2015-11-24, terminated 2016-06-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.. Reason: The sterile blade will not fit into the handle provided with the ETTD system..
- Recalling firm
- Instratek, Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-24
- Terminated
- 2016-06-27
- Firm location
- Houston, TX, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.