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U.S. Department of Health and Human Services

Class 2 Device Recall Zero tip

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  Class 2 Device Recall Zero tip see related information
Date Initiated by Firm December 20, 2005
Date Posted February 08, 2006
Recall Status1 Terminated 3 on May 01, 2007
Recall Number Z-0510-06
Recall Event ID 34300
Product Classification Dislodger, Stone, Basket, Ureteral, Metal - Product Code FFL
Product Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 90 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-104.
Code Information All units.
Recalling Firm/
Manufacturer		 Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information Contact Cindy Finney
508-683-4678
Manufacturer Reason
for Recall		 The basket wire assembly may detach from the drive wire while in the patient.
FDA Determined
Cause 2		 Other
Action U.S. and foreign consignees were notified via letter dated 12/20/05 and requested to return stocks on hand. Distributors were requested to notify their customers.
Quantity in Commerce 2076
Distribution Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Chile, Denmark, Dominican Republic, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, South Korea, Singapore, South Africa, Spain and Sweden.
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.
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