The Recall Desk
HighFDA (Devices)·Z-2462-2026·Announced 2026-06-24

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

Pending LLM rewrite. Source: FDA_DEVICE Z-2462-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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).

The recalled product

Product
TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
Manufacturer
Howmedica Osteonics Corp.

Distribution

Distributed nationwide across the United States.