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.
FDA Recall Z-1864-2008 · Posted 2008-09-16
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2005-05-27
Date Terminated2008-09-24
Product Quantity560 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
To Stryker branches/agencies worldwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.