—#70990

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.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number: 6541-1-603 All lots (ecxept lot codes NMZC01, NMYV01, NMYW03.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: To Stryker branches/agencies worldwide.

Timeline

Recall initiated: 2005-05-27
Posted by FDA: 2008-09-16
Terminated: 2008-09-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70990. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.