Reported Oct 17, 2018 · Terminated

Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used…

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?

  • Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
Lot codes and dates
    • Part number 8735-05
    • Lot number 90212
Amount recalled
217 units

Where it was sold

  • Nationwide

Why it was recalled

Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Implant Direct Sybron Manufacturing, LLC recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 29, 2020 · Data as of Sep 19, 5:33 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.