Recall Z-1864-2008 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
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 referenci
| Date | Sep 16, 2008 (initiated May 27, 2005) |
| Status | Terminated |
| Reason | 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 | 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 | 560 units |
| Distribution | To Stryker branches/agencies worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.