Triathlon Femoral Sizer - The Femoral sizer was developed for use with the Triathlon Total Knee Instrumentation system.
FDA device recall Z-1864-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 560 units
- Distribution
- To Stryker branches/agencies worldwide.
- Date initiated
- 2005-05-27
- Date posted
- 2008-09-16
- Date terminated
- 2008-09-24
- Location
- Mahwah, NJ
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