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U.S. Department of Health and Human Services

Class 2 Device Recall Zilver

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  Class 2 Device Recall Zilver see related information
Date Initiated by Firm January 08, 2002
Date Posted August 26, 2003
Recall Status1 Terminated 3 on March 21, 2005
Recall Number Z-1181-03
Recall Event ID 26966
510(K)Number K020788  
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Product Zilver Expandable Metal Biliary Stent
Code Information Reorder #ZILBS-6-6

ZILBS-10-8, ZILBS10-6, Amended 8/8/2003 to include: ZILBS-10-4, ZILBS-8-4, ZILBS-8-6, ZILBS-8-8, ZILBS6-4, ZILBS-6-8
Recalling Firm/
Wilson-Cook Medical Inc
4900 Bethania Station Rd
& 5951 Grassy Creek Blvd.
Winston-Salem NC 27105
For Additional Information Contact Sharon Miles
Manufacturer Reason
for Recall
The inner catheter of the introducer system may break after stent deployment.
FDA Determined
Cause 2
Action Initially the firm conducted a Market Withdrawal on January 8, 2002. Subsequently the firm initiated a recall, notifying consignees via letter on 8/8/2003. A Customer Response Form was attached.
Quantity in Commerce 57 units
Distribution The product was distributed to hospitals located nationwide and worldwide.
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = WILSON-COOK MEDICAL, INC.