Z-1013-2009

Triathlon X3 Posterior Stabilized Tibial Insert Use with Triathlon PS Femoral Components. Sze 7, THKNS 13 m...

Name: Z-1013-2009 Triathlon X3 Posterior Stabilized Tibial Insert Use with Triathlon PS Femoral Components. Sze 7, THKNS 13 m...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2008-12-18
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2008-12-18 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Triathlon X3 Posterior Stabilized Tibial Insert Use with Triathlon PS Femoral Components. Sze 7, THKNS 13 m and SZE 8, THKNS 13mm; Catalog number 5532-G-713... on 2008-12-18. The reason FDA records is "Stryker Orthopaedics became aware of a lot for lot mix-up between part numbers 5532-G-713, lot code LBD528 (Triathlon X3 Posterior Stabilized Tibial Insert, size 7-13 mm) and part 5532-G-813, lot code LBD512 (Triathlon...". 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-1013-2009
Status: Terminated
Initiated: 2008-12-18
Posted: 2009-03-03
Terminated: 2012-09-11
Recalling firm: Howmedica Osteonics Corp
Product: Triathlon X3 Posterior Stabilized Tibial Insert Use with Triathlon PS Femoral Components. Sze 7, THKNS 13 m and SZE 8, THKNS 13mm; Catalog number 5532-G-713, Catalog number 5532-G-813 Stryker Orthopaedics
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Stryker Orthopaedics became aware of a lot for lot mix-up between part numbers 5532-G-713, lot code LBD528 (Triathlon X3 Posterior Stabilized Tibial Insert, size 7-13 mm) and part 5532-G-813, lot code LBD512 (Triathlon X3 Posterior Stabilized Tibial Insert Size 8-13 mm)
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Urgent Product Recall letters were sent via Federal Express on December 18, 2008 with return receipt to Stryker branches, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter stated the issue, the potential hazards, and the risk mitigation factors. The firm asked customers to examine their inventory and hospital locations to identify affected product; retrieve all affected product and return it to their branch or agency warehouse for reconciliation; reconcile all products on the attached Product Accountability Form; and return affected product. Questions should be directed to Karen Ariemma at 201-831-5718.
Quantity in commerce: 9 of lot code LBD528; 14 of lot code LBD512
Distribution: Nationwide Distribution: FL and IL.
Product codes and lots: Lot code LBD528 and Lot code LBD512.

Product code JWH

K051146Class IITriathlon Knee SystemHowmedica Osteonics Corp. / cleared 2005-07-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)