Class 2 Device Recall Spiral Z

• Date Initiated by Firm: January 08, 2002
• Date Posted: August 26, 2003
• Recall Status: Terminated on March 21, 2005
• Recall Number: Z-1179-03
• Recall Event ID: 26966
• 510(K)Number: K941350
• Product Classification: Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
• Product: Spiral Z Expandable Metal Biliary Stent
• Code Information: Reorder #SZBS-10-7.5-C, Amended 8/8/2003 to include SZBS-10-5.7-C
• Recalling Firm/ Manufacturer: Wilson-Cook Medical Inc; 4900 Bethania Station Rd; & 5951 Grassy Creek Blvd.; Winston-Salem NC 27105
• For Additional Information Contact: Sharon Miles; 336-744-0157
• Manufacturer Reason for Recall: The inner catheter of the introducer system may break after stent deployment.
• FDA Determined Cause: Other
• 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: 23 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