Class 2 Device Recall

• Date Initiated by Firm: June 27, 2003
• Date Posted: July 23, 2003
• Recall Status: Terminated on February 04, 2004
• Recall Number: Z-1042-03
• Recall Event ID: 26691
• Product Classification: Gown, Surgical - Product Code FYA
• Product: ProVision Barrier Universal Hood/Gown; product 5431-33-000
• Code Information: All product manufactured between February 1, 2002 and June 17, 2003 that does not have a green square on the label above the CE mark. Product bearing the green square on the label has been 100% inspected and is not under recall.
• Recalling Firm/ Manufacturer: Depuy Orthopaedics, Inc.; 700 Orthopaedic Drive; Warsaw IN 46581
• For Additional Information Contact: Customer Service; 800-366-8143
• Manufacturer Reason for Recall: Lack of assurance of sterility, due to the possibility of an incomplete package seal.
• FDA Determined Cause: Other
• Action: An Urgent Recall Notice was sent to customers on June 27, 2003 via federal express. Customers were instructed to locate all affected inventory and to immediately return it to Depuy.
• Distribution: United States, Australia, Canada, Chile, England, India, Japan, Malaysia, Singapore, South Africa, Taiwan and United Kingdom
• 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.