Reported Oct 1, 2014 · Terminated

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

Instratek, Incorporated

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Instratek, Incorporated · 15200 Middlebrook Dr · Houston, TX · 77058-1216

Is this the product you have?

  • 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
Lot codes and dates
    • Mini System part no. IS1100 - lot 0001-0047
    • Instrument part nos. IS1103
    • IS1104
    • and IS1105 - lots 918101
    • 918102
    • and 918103
Amount recalled
96

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 26, 2016 · Data as of Sep 19, 6:15 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.