Reported Jul 11, 2018 · Terminated

REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60

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?

    • REPLANT 5.0mmD ABUTMENT
    • Part number 6050-52-60
Lot codes and dates
  • Lot numbers
    • 45353
    • 66011
    • and 75850
Amount recalled
60 units

Where it was sold

Why it was recalled

Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant

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 Jul 13, 2020 · Data as of Sep 19, 5:22 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.