Reported Dec 23, 2020 · Terminated

6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929,…

Biomet, Inc.

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, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989

Is this the product you have?

    • 6.5/8.0mm Cannulated Screw System
    • BCS Cannulated Screw System (3.0
    • 4.0/5.0
    • 6.5/8.0mm)
    • Item numbers 110009929
    • 110009934
    • 110009935
    • 110009936
    • 110009993
    • 110009994
    • 110009996
    • 110009998
    • 110010000
    • 110010003
    • 110010029
    • 110010030
    • 110010032
    • 110010099 -
  • Product UsageFracture fixationof small bones, small bone fragements and long bones
Lot codes and dates
  • Lots
    • 167600
    • 288790
    • 286450
    • 368030
    • 180660
    • 285790
    • 285800
    • 179940
    • 179960
    • 179980
    • 180020
    • 288880
    • 288890
    • 288750
    • 179750
Amount recalled
7428

This recall covers 16 products

The agency filed one notice per product. You are reading one of them; the other 15 are below.

3 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

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 May 8, 2024 · Data as of Sep 19, 6:56 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.