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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 27, 2003
Date Posted July 23, 2003
Recall Status1 Terminated 3 on February 04, 2004
Recall Number Z-1040-03
Recall Event ID 26691
510(K)Number K972832  
Product Classification Gown, Surgical - Product Code FYA
Product ProVision Hytrel Elastomer Hood; product 5431-05-000.
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/
Depuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw IN 46581
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
Lack of assurance of sterility, due to the possibility of an incomplete package seal.
FDA Determined
Cause 2
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.
510(K) Database 510(K)s with Product Code = FYA and Original Applicant = DEPUY, INC.