Reported May 31, 2017 · Terminated

Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD

Implant Direct Sybron Manufacturing, LLC

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: Implant Direct Sybron Manufacturing, LLC · 3050 E Hillcrest Dr · Westlake Village, CA · 91362-3171

Is this the product you have?

  • Legacy Full Contour Laboratory Abutment3.5mmD Platform/5.5mmD
Lot codes and dates
    • 89103
    • 83493
    • 78986
Amount recalled
151 units

Where it was sold

  • Nationwide
  • DE

Why it was recalled

Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.

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 8, 2018 · Data as of Sep 19, 4:45 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.