—#53813

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

FDA product code: KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: All lots.

Why it was recalled

Package Integrity: The outer peelable pouch seals may be compromised due to creasing, although the inner pouch seals are intact.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Depuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2007-07-13
Posted by FDA: 2007-11-17
Terminated: 2009-06-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #53813. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.