Depuy Orthopaedics, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Depuy Orthopaedics, Inc.
Lot Codes / Batch Numbers
All lots.
Products Sold
All lots.
Depuy Orthopaedics, Inc. is recalling SmartSeal Wedge Femoral Pressuriser; Product Code/Catalog No: 3206002, DePuy Orthopaedics, Inc., 700 due to Package Integrity: The outer peelable pouch seals may be compromised due to creasing, although the inner pouch seals are intact.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Package Integrity: The outer peelable pouch seals may be compromised due to creasing, although the inner pouch seals are intact.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026