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Class 2 Device Recall |
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Date Initiated by Firm |
June 27, 2003 |
Date Posted |
July 23, 2003 |
Recall Status1 |
Terminated 3 on February 04, 2004 |
Recall Number |
Z-1043-03 |
Recall Event ID |
26691 |
510(K)Number |
K972832
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Product Classification |
Gown, Surgical - Product Code FYA
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Product |
ProVision Disposable Hood; product 5431-50-000 |
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/ Manufacturer |
Depuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw IN 46581
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For Additional Information Contact |
Customer Service 800-366-8143
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Manufacturer Reason for Recall |
Lack of assurance of sterility, due to the possibility of an incomplete package seal.
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FDA Determined Cause 2 |
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. |
Distribution |
United States, Australia, Canada, Chile, England, India, Japan, Malaysia, Singapore, South Africa, Taiwan and United Kingdom |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = FYA and Original Applicant = DEPUY, INC.
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