Reported Jan 13, 2016 · Terminated

InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage:…

Ultradent Products, Inc.

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: Ultradent Products, Inc. · 505 W 10200 S · South Jordan, UT · 84095-3935

Is this the product you have?

    • InterGuard 5.5mm Econo Refill
    • sizes
    • 4.0mm for short anatomical crowns and 5.5mm
    • part # 4012
  • Product UsageInterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel preparations as well as air abrasion
Lot codes and dates
  • lot#s BC2GN and BC4L7
Amount recalled
157

Where it was sold

  • Nationwide

Why it was recalled

Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from the supplier with the floss tether hole not completely punched through and were distributed.

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 Oct 19, 2016 · Data as of Sep 19, 6:01 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.