Z-1864-2008

Triathlon Femoral Sizer - The Femoral sizer was developed for use with the Triathlon Total Knee...

Name: Z-1864-2008 Triathlon Femoral Sizer - The Femoral sizer was developed for use with the Triathlon Total Knee...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2005-05-27
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2005-05-27 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Triathlon Femoral Sizer - The Femoral sizer was developed for use with the Triathlon Total Knee Instrumentation system. It interfaces with the Modular Handled... on 2005-05-27. The reason FDA records is "Stryker Orthopaedics became aware that when attempting to position the Triathlon Femoral Sizer, the pre-setting may slip from l (left knee) to R (right knee) and vice verse intraoperatively". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1864-2008
Status: Terminated
Initiated: 2005-05-27
Posted: 2008-09-16
Terminated: 2008-09-24
Recalling firm: Howmedica Osteonics Corp
Product: Triathlon Femoral Sizer - The Femoral sizer was developed for use with the Triathlon Total Knee Instrumentation system. It interfaces with the Modular Handled and the Femoral Stylus to facilitate sizing for a femoral component, and preparing holes to accept the corresponding 4:1 Cutting Guide. The femoral sizer is designed to prepare the femoral cuts in 3 degrees of external rotation by referencing against the posterior condyles. The Femoral sizer is set by locking it into the left or right orientation based on the femur.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Stryker Orthopaedics became aware that when attempting to position the Triathlon Femoral Sizer, the pre-setting may slip from l (left knee) to R (right knee) and vice verse intraoperatively.
Root cause tag: design
FDA root cause: Device Design
Action: Letters were sent to all affected Stryker Branches/Agencies on May 27, 2005. Letters requested that each branch examine the inventory and hospitals locations to identify the instruments. Contact James Young at 201-831-5110, Brian Coughlin at 210-831-5665 or Rita Intorrella at 201-831-5825 if you have questions.
Quantity in commerce: 560 units
Distribution: To Stryker branches/agencies worldwide.
Product codes and lots: Catalog Number: 6541-1-603 All lots (ecxept lot codes NMZC01, NMYV01, NMYW03.

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)