Depuy Orthopaedics, Inc. ProVision Hytrel Universal Hood/Gown; product 5431-31-000 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ProVision Hytrel Universal Hood/Gown; product 5431-31-000
Brand
Depuy Orthopaedics, Inc.
Lot Codes / Batch Numbers
All product manufactured between February 1, 2002 and June 17
Products Sold
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.
Depuy Orthopaedics, Inc. is recalling ProVision Hytrel Universal Hood/Gown; product 5431-31-000 due to Lack of assurance of sterility, due to the possibility of an incomplete package seal.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of assurance of sterility, due to the possibility of an incomplete package seal.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026