Reported Mar 25, 2015 · Terminated

Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon…

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?

  • Triathlon
  • Distal Capture Assembly Catalog No6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA)
Lot codes and dates
  • 93 of 93 codes

    • ER5ND5
    • ER6EG4
    • ER5NE4
    • ER6EG5
    • ER5NE4M
    • ER6EG5A
    • ER6CG9
    • ER6KA1
    • ER6CG9A
    • ER6KA2
    • ER6CH1
    • ER6KA3
    • ER6CH1A
    • ER6KA3A
    • ER6CH1D
    • ER6KA3T
    • ER6CH1M
    • ER6KA4
    • ER6ED1
    • ER6KA5
    • ER6ED1A
    • ER6KA6
    • ER6ED2
    • ER6KA7
    • ER6ED3
    • ER6KA7T
    • ER6ED4
    • ER6KA8
    • ER6ED5
    • ER6KA8T
    • ER6ED6
    • ER6KA9
    • ER6ED7
    • ER6KD1
    • ER6ED7E
    • ER6KD2
    • ER6ED8
    • ER6KD3
    • ER6ED8J
    • ER6KD4
    • ER6ED9
    • ER6KD5
    • ER6EE1Y
    • ER6KD6
    • ER6EE2
    • ER6KD7
    • ER6EE6
    • ER6MA3
    • ER6EE6M
    • ER6MA4
    • ER6EE7
    • ER6SA3
    • ER6EE7J
    • ER6SA3J
    • ER6EF2
    • ER6SA3X
    • ER6EF3
    • ER6SA4
    • ER6EF3A
    • ER7MA3
Amount recalled
2030 units

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Potential for weld disassociation of the cross pin, which could lead to loose or disassociated trigger mechanism on the Distal Capture Assembly.

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 Jul 5, 2016 · Data as of Sep 19, 6:15 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.