Z-0176-2008

SmartSeal Wedge Femoral Pressuriser; Product Code/Catalog No: 3206002, DePuy Orthopaedics, Inc., 700...

Name: Z-0176-2008 SmartSeal Wedge Femoral Pressuriser; Product Code/Catalog No: 3206002, DePuy Orthopaedics, Inc., 700...
Creator: Depuy Orthopaedics, Inc.
Published: 2007-07-13
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2007-07-13 / Terminated / root cause: packaging

FDA source

Depuy Orthopaedics, Inc. began a recall of SmartSeal Wedge Femoral Pressuriser; Product Code/Catalog No: 3206002, DePuy Orthopaedics, Inc., 700 Orthopaedics Drive, Warsaw, Indiana 46581-0988-This... on 2007-07-13. The reason FDA records is "Package Integrity: The outer peelable pouch seals may be compromised due to creasing, although the inner pouch seals are intact". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0176-2008
Status: Terminated
Initiated: 2007-07-13
Posted: 2007-11-17
Terminated: 2009-06-23
Recalling firm: Depuy Orthopaedics Inc.
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
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: Package Integrity: The outer peelable pouch seals may be compromised due to creasing, although the inner pouch seals are intact.
Root cause tag: packaging
FDA root 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.
Product codes and lots: All lots.

Product code KWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)