FDA Medical Device Recalls (openFDA)
Depuy Orthopaedics, Inc.: ProVision Disposable Hood; product 5431-50-000
- Recall number
- Z-1043-03
- Recalling firm
- Depuy Orthopaedics, Inc.
- Product
- ProVision Disposable Hood; product 5431-50-000
- Status
- Terminated
- Initiated
- 2003-06-27
- Posted
- 2003-07-23
- Terminated
- 2004-02-04
- Reason
- Lack of assurance of sterility, due to the possibility of an incomplete package seal.
- Root 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.
- Quantity
- not on file
- Distribution
- United States, Australia, Canada, Chile, England, India, Japan, Malaysia, Singapore, South Africa, Taiwan and United Kingdom
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K972832"]
- PMA numbers
- not on file
- Product code
- FYA
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28