Reported Mar 13, 2024 · Ongoing

NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM

Howmedica Osteonics Corp.

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: Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006

Is this the product you have?

  • NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
Lot codes and dates
  • Part No. 5537-G-513-E
  • GTIN
    • 07613327287813
    • Lot No. 9M3A91
    • EV0DV0
  • Expiration Date10/07/2028
Amount recalled
37 units (US); 10 units (OUS)

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

  • Nationwide

Why it was recalled

Potential packaging breaches of inner blister and outer sterile blister.

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

Data as of Sep 19, 4:55 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.