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.
Recall
- Recall Number
- Z-1864-2008
- Event Number
- 48200
- Firm
- Stryker Howmedica Osteonics Corp.
- FEI Number
- 3003070421
- Product Code
- LXH
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- May 27, 2005
- Posted
- September 16, 2008
- Terminated
- September 24, 2008
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2002
Description
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.
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.
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.
To Stryker branches/agencies worldwide.
560 units