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

FDA device recall Z-0176-2008 · posted 2007-11-17 · Terminated

Recall details

Recalling firm

Depuy Orthopaedics, Inc.

Reason for recall

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

Action taken

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.

Root cause

Packaging process control

Status

Terminated

Product code

KWS

Quantity affected

3,530

Distribution

Nationwide Distribution -- including States of Arkansas, California, Colorado, Florida, Idaho, Illinois, Indiana, Kentucky, Maine, Michigan, Mississippi, New Mexico, North Carolina, Pennsylvania, Sout

Date initiated

2007-07-13

Date posted

2007-11-17

Date terminated

2009-06-23

Location

Warsaw, IN