Z-2360-2015Class II

Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm

Name: Z-2360-2015 Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm
Creator: Stryker Howmedica Osteonics Corp.
Published: 2015-05-29
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2015-05-29 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx... on 2015-05-29. FDA classified it as Class II and gives the reason as "Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2360-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-29
Posted: 2015-08-10
Terminated: 2016-07-25
Recalling firm: Howmedica Osteonics Corp
Product: Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial baseplate where it serves as the bearing component for the articulating surface of a corresponding Triathlon femoral component.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Stryker Orthopaedics sent an Urgent Medical Device Recall Notification letter dated July 9, 2015 and Product Accountability Forms via return receipt. The letter identified the affected product, problem, potential hazard, risk mitigation and actions to be taken. Contact Stryker Orthopaedics Sales Representative to arrange for return of the affected product. For questions call 201-831-5826.
Quantity in commerce: 26 units
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: Catalog Number 5532-G-511 Lot LD8D7Y Catalog Number 5537-G-319 Lot TT6JT2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2360-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2360-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-19	2015-08-10

Product code JWH

K141056Class IITriathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics / cleared 2014-08-05

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)