Instratek, Incorporated

FDA Regulatory Profile

Instratek, Incorporated appears in FDA public data with 3 recalls, 0 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0469-2016, Class II) was initiated on November 24, 2015.

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0469-2016Class IIHook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal TunNovember 24, 2015
Z-2679-2014Class IIMini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gaApril 25, 2013
Z-0922-2013Class IIEndotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to releasSeptember 18, 2012