Agency classClass IIOur severity:High FDA (Devices)·Z-2462-2026·Announced 2026-06-24

Stryker Triathlon size 4 baseplate packaging contained a size 3 implant

Triathlon Universal Baseplate Size 4 packaging is being recalled after Stryker identified that it contained a Size 3 baseplate, and vice versa. Seven units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II recall where the implant inside the box is a different size from the label, a risk of harm with no injuries reported in the source.

Plain-English summary

The TRI TS Baseplate Size 4, part number 5521-B-400, UDI (01)07613327026061(17)260921(10)TYX7OB, lot TYX7OB, is being recalled. The action covers seven units.

Stryker has identified that the Triathlon Universal Baseplate Size 3 (lot UZD9IB) is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and that the Size 4 baseplate (lot TYX7OB) is contained in packaging labeled as Size 3 (lot UZD9IB). The FDA classified the action as Class II.

Distribution was within the United States, in Arizona, California, Georgia, Michigan, North Carolina, New Jersey, New York and West Virginia. The baseplates are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the part number, UDI and lot number above, quarantine it, and follow the instructions issued by Stryker.

The recalled product

Product: TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
Manufacturer: Howmedica Osteonics Corp.
Category: Medical Device — Knee implant component
Hazard: wrong-size
mislabeled-packaging
implant
class-ii
Affected units: 7

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Howmedica Osteonics Corp.

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Same hazard · wrong size