Instratek, Incorporated
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0469-2016 | Class II | Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tun | November 24, 2015 |
| Z-2679-2014 | Class II | Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth ga | April 25, 2013 |
| Z-0922-2013 | Class II | Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to releas | September 18, 2012 |