Z-3198-2026Class II

TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic...

Name: Z-3198-2026 TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic...
Creator: Howmedica Osteonics Corp.
Published: 2026-07-30
License: https://open.fda.gov/license/

Howmedica Osteonics Corp. / initiated 2026-07-30 / Open, Classified

FDA source

Recall record

Recall number: Z-3198-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-30
Posted: 2026-09-16
Recalling firm: Howmedica Osteonics Corp.
Product: TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
FDA root cause: Process change control
Action: Firm began notifying customers on July 30, 2026, via FedEx 2-day air. Customers were instructed to quarantine and discontinue use of the affected product. Affected product should be returned to the firm.
Quantity in commerce: 12,156 US
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
Product codes and lots: 5612-P-411 UDI-DI 07613327601893 Lot 360958 5612-P-413 UDI-DI 07613327602012 Lot 354573

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3198-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3195-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3196-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3197-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3198-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3199-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3200-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3201-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3202-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3203-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3204-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3205-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3206-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16

Product code KRO

K223528Class IITriathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics / cleared 2023-01-20

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 2026-09-23. View this recall on fda.gov (opens on fda.gov)