Reported May 2, 2018 · Terminated

Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use…

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?

  • Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.
Lot codes and dates
    • Catalog #5545-A-301
    • lot code ER9WA1A
    • ER9WA1D
    • ER9WA1E Catalog #5546-A-601
    • lot code ER9MA5A
Amount recalled
77 total products

This recall covers 2 products

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

Where it was sold

Why it was recalled

Customers may receive the incorrect size implant from what is labeled on the box.

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 7, 2020 · Data as of Sep 19, 4:51 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.