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Recall Observatory FDA recall evidence

Device product

TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.

Z-2462-2026

May 19, 2026

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 99080
Status
Ongoing
Classification
Class II
Quantity
7 units
Official record key
device-enforcement:Z-2462-2026

Official wording

Reason: 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).

Code information: Part Number: 5521-B-400. UDI: (01)07613327026061(17)260921(10) TYX7OB. Lot Number: TYX7OB.

Distribution pattern: US Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).