Class II recallOngoing

TRI TS BASEPLATE SIZE 3 recall — FDA event 99080

FDA · FDA event 99080 · Posted Jun 17, 2026

Published Jun 17, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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).

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

Stryker notified consignees on about 05/19/2026 via letter sent using FedEx 2-day service. Consignees were instructed to inform users of the Urgent Medical Device Recall and forward the notice to all individuals who need to be made aware or organizations who have consigned product, immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are on hand, and complete and return the provided Urgent Medical Device Recall Business Reply Form.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists TRI TS BASEPLATE SIZE 3 by Stryker Corporation.

Products affected by FDA event 99080
Model	Description	Lot / serial range	Manufactured	Status
Z-2462-2026	Z-2462-2026	Part Number: 5521-B-400. UDI: (01)07613327026061(17)260921(10) TYX7OB. Lot Number: TYX7OB.	Not provided in the normalized record	Ongoing
Z-2461-2026	Z-2461-2026	Part Number: 5521-B-300. UDI: (01)07613327026313(17)260921(10) UZD9IB. Lot Number: UZD9IB.	Not provided in the normalized record	Ongoing

Distribution: US Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV.
Units affected: See official FDA record
Category: Knee implants

Timeline

May 19, 2026
Recall initiated
Date recorded by the FDA.
Jun 17, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 99080
Published: Jun 17, 2026
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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TRI TS BASEPLATE SIZE 3 recall — FDA event 99080

FDA · FDA event 99080 · Posted Jun 17, 2026

Published Jun 17, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

This FDA record lists TRI TS BASEPLATE SIZE 3 by Stryker Corporation.

Products affected by FDA event 99080
Model	Description	Lot / serial range	Manufactured	Status
Z-2462-2026	Z-2462-2026	Part Number: 5521-B-400. UDI: (01)07613327026061(17)260921(10) TYX7OB. Lot Number: TYX7OB.	Not provided in the normalized record	Ongoing
Z-2461-2026	Z-2461-2026	Part Number: 5521-B-300. UDI: (01)07613327026313(17)260921(10) UZD9IB. Lot Number: UZD9IB.	Not provided in the normalized record	Ongoing

Distribution

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

Units affected

See official FDA record

EMPOWR 3D KNEE INS, 11L 14MM, VE recall — FDA event 98700

Due to packaging discrepancy with incorrect product size mixed up.

FDA · FDA event 98700Posted Jul 8, 2026

Class II recallOngoing

Persona Revision Trabecular Metal Femoral Distal Augment recall — FDA event 99073

Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

FDA · FDA event 99073Posted Jun 24, 2026

Class II recallOngoing

Endo-Model SL Connection Component incl recall — FDA event 98342

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

FDA · FDA event 98342Posted Mar 10, 2026

TRI TS BASEPLATE SIZE 3 recall — FDA event 99080

Follow TRI TS BASEPLATE SIZE 3

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

TRI TS BASEPLATE SIZE 3 recall — FDA event 99080

Follow TRI TS BASEPLATE SIZE 3

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline