Reported Aug 24, 2016 · Terminated

O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 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?

  • O-Ring Abutment 4.1mm(D)
  • x 4mm(H) ItemOSO40 Dental implants
Lot codes and dates
    • Lot # 1014104
    • 1022991
    • 1033058
    • 1041417
    • 1052716
    • 1054542
    • 1060675
    • 1069646
    • 1088483
    • 1094776
    • 1106610
    • 1129686
    • 1141289
    • 1168523
    • 1168829
    • 1172024
    • and 996069
Amount recalled
1,648,273 (all products subject to these 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.

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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, 5:18 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.