FDA-Device2014-10-01Class II

Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System

Instratek, Incorporated
Hazard

Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.

Sold states
Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado
Affected count
96
Manufactured in
15200 Middlebrook Dr, Ste G, Houston, TX, United States
Products
Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2679-2014

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