Reported Aug 1, 2018 · Terminated

ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of…

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 · Thousand Oaks, CA · 91362

Is this the product you have?

  • ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Lot codes and dates
  • Lot #87837
Amount recalled
124 units

Where it was sold

Why it was recalled

The main vial label lists the incorrect part number, but the cap label is correct.

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 Aug 6, 2018 · Data as of Sep 19, 4:52 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.