Reported Jul 9, 2014 · Terminated

Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella…

Stryker 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: Stryker Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2002

Is this the product you have?

  • Stryker Orthopaedics Triathlon Tritanium Patella Inserter
  • NON-STERILE Product UsageThe Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using the existing Triathlon Patella Resection Guide, Metal Backed Patella Drill and Patella Peg Drill Templates as per the Triathlon Tritanium Surgical Protocol
Lot codes and dates
  • Catalog No. 6541-3-530
  • Lot CodesCTD2778 and CTD2779
Amount recalled
22 Units

Where it was sold

Why it was recalled

Tritanium Patella Inserter Instrument fracture during implantation. .

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 Jun 9, 2017 · Data as of Sep 19, 6:00 PM UTC

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