ProVision Disposable Hood; product 5431-50-000
FDA device recall Z-1043-03 · posted 2003-07-23 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- Reason for recall
- Lack of assurance of sterility, due to the possibility of an incomplete package seal.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FYA
- Distribution
- United States, Australia, Canada, Chile, England, India, Japan, Malaysia, Singapore, South Africa, Taiwan and United Kingdom
- Date initiated
- 2003-06-27
- Date posted
- 2003-07-23
- Date terminated
- 2004-02-04
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROVISION SURGICAL HELMET SYSTEM (K972832) | Depuy, Inc. | 1997-10-21 |