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.
This recall has been terminated (originally issued September 16, 2008).
- Recall Initiated
- May 27, 2005
- Posted
- September 16, 2008
- Terminated
- September 24, 2008
- Recall Number
- Z-1864-2008
- Quantity
- 560 units
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
To Stryker branches/agencies worldwide.
Lot / Code Info
Catalog Number: 6541-1-603 All lots (ecxept lot codes NMZC01, NMYV01, NMYW03.
Root Cause
Device Design
Action Taken
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.
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