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Devices
ProVision Hytrel Elastomer Hood; product 5431-05-000.
Model / Serial
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.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
United States, Australia, Canada, Chile, England, India, Japan, Malaysia, Singapore, South Africa, Taiwan and United Kingdom
Product Description
ProVision Hytrel Elastomer Hood; product 5431-05-000.
Manufacturer
Depuy Orthopaedics, Inc.
1 Event
Recall of ProVision Hytrel Elastomer Hood; product 5431-05-000.
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Manufacturer
Depuy Orthopaedics, Inc.
Manufacturer Address
Depuy Orthopaedics, Inc., 700 Orthopaedic Drive, Warsaw IN 46581
Source
USFDA
Language
English
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