Date Initiated by Firm | May 27, 2005 |
Date Posted | September 16, 2008 |
Recall Status1 |
Terminated 3 on September 24, 2008 |
Recall Number | Z-1864-2008 |
Recall Event ID |
48200 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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Product | 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. |
Code Information |
Catalog Number: 6541-1-603 All lots (ecxept lot codes NMZC01, NMYV01, NMYW03. |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
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For Additional Information Contact | Colleen O'Meara 201-831-5000 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 560 units |
Distribution | To Stryker branches/agencies worldwide. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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