Z-2462-2026Class II

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

Name: Z-2462-2026 TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400
Creator: Howmedica Osteonics Corp.
Published: 2026-05-19
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2026-05-19 / Open, Classified / root cause: labeling and UDI

FDA source

Howmedica Osteonics Corp. began a recall of TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400 on 2026-05-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2462-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-19
Posted: 2026-06-17
Recalling firm: Howmedica Osteonics Corp
Product: TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: 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).
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 7 units
Distribution: US Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV.
Product codes and lots: Part Number: 5521-B-400. UDI: (01)07613327026061(17)260921(10) TYX7OB. Lot Number: TYX7OB.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2462-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2461-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2462-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17

Product code MBH

K123486Class IITriathlon Tritanium Tibial BaseplateStryker / cleared 2013-05-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)