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This is part of a larger recall. The most authoritative record is FDA-Device / Z-2461-2026.

FDA-Device2026-06-24Class IIMISBRANDING

Stryker Triathlon Universal Baseplate Size 3 and 4 recalled for mislabeling

Howmedica Osteonics
LABEL MIX UPNationwide distribution

Stryker Triathlon baseplates recalled for mislabeling

Stryker identified that Triathlon Universal Baseplate Size 3 components were packaged in boxes labeled as Size 4, and Size 4 components were packaged in boxes labeled as Size 3. This labeling error affects two specific lots and could result in implanting the wrong size component during surgery.

  • Check your inventory for Triathlon Universal Baseplate lots UZD9IB (labeled Size 4) and TYX7OB (labeled Size 3).
  • Do not use these components until you verify the actual size by opening the package and inspecting the baseplate itself.
  • Contact Stryker for replacement components or further instructions.
Hazard

Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).

Sold states
US Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV.
Affected count
7 units
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2462-2026

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