Reported Aug 24, 2016 · Terminated

Certain Conical Abutment Dental implants

Biomet 3i, 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: Biomet 3i, LLC · 4555 Riverside Dr · Palm Beach Gardens, FL · 33410-4200

Is this the product you have?

  • Certain Conical Abutment Dental implants
Lot codes and dates
  • Items
    • IMCA31
    • IMCA32
    • IMCA33
    • IMCA34
    • ICA001
    • ICA002
    • ICA003
    • ICA004
    • IWCA51
    • IWCA52
    • IWCA53
    • IWCA54 and IWCA55
Amount recalled
1,648,273 devices (all products subject to this recall)

This recall covers 119 products

The agency filed one notice per product. You are reading one of them; the other 118 are below.

106 more are in the archive.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Pouches may not have been sealed during packing.

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.

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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 26, 2019 · Data as of Sep 19, 6:03 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.