FDA-Device2026-06-24Class IIMISBRANDING

Howmedica Osteonics Triathlon Universal Baseplate Size 3 recalled for mislabeling with wrong size

LABEL MIX UPNationwide distributionMedical devices

What this means

Stryker identified that some Triathlon Universal Baseplate Size 3 units (lot UZD9IB) were packaged in boxes labeled as Size 4, while Size 4 units (lot TYX7OB) were packaged in boxes labeled as Size 3. This labeling mix-up could result in using the wrong implant size during surgery.

  • If you received a Triathlon Universal Baseplate Size 3 (lot UZD9IB) or Size 4 (lot TYX7OB), verify the actual implant size matches the box label before use.
  • Contact Stryker or your distributor if you have units from the affected lots.
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The agency's original wording
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).

Intended for
Adults
Illnesses reported
None reported
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 3. Part Number: 5521-B-300.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2461-2026

Also reported as

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