Class 2 Device Recall SmartSeal Wedge Femoral Pressuriser

• Date Initiated by Firm: July 13, 2007
• Date Posted: November 17, 2007
• Recall Status: Terminated on June 23, 2009
• Recall Number: Z-0176-2008
• Recall Event ID: 38464
• Product Classification: Femoral Pressuriser - Product Code KWS
• Product: SmartSeal Wedge Femoral Pressuriser; Product Code/Catalog No: 3206002, DePuy Orthopaedics, Inc., 700 Orthopaedics Drive, Warsaw, Indiana 46581-0988-This product allows for effective and controlled pressurization of bone cement into the femur and the acetabulum during hip arthroplasty procedures
• Code Information: All lots.
• Recalling Firm/ Manufacturer: Depuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: Customer Service; 800-366-8143
• Manufacturer Reason for Recall: Package Integrity: The outer peelable pouch seals may be compromised due to creasing, although the inner pouch seals are intact.
• FDA Determined Cause: Packaging process control
• Action: Sales Force Managers were notified of this recall by an Urgent Information Recall Notice Letter, via email, on 7/13/07 and 7/23/07, to visit their Consignees. Letters for the Hospitals (Dear Materials Manager) and Dear Doctors Letters were provided as background by the Sales Force Managers during their visits. If any product remained in inventory, it should be quarantined immediately, and returned to DePuy. Hospitals should be notified immediately not to use the affected device. Replacement stocks will have a check mark on the bottom right front of package to indicate it has passed inspection.
• Quantity in Commerce: 3,530
• Distribution: Nationwide Distribution -- including States of Arkansas, California, Colorado, Florida, Idaho, Illinois, Indiana, Kentucky, Maine, Michigan, Mississippi, New Mexico, North Carolina, Pennsylvania, South Dakota, Texas, Utah and Washington.
• Total Product Life Cycle: TPLC Device Report

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.