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U.S. Department of Health and Human Services

Class 2 Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter

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  Class 2 Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter see related information
Date Initiated by Firm November 25, 2003
Date Posted December 17, 2003
Recall Status1 Terminated 3 on May 09, 2012
Recall Number Z-0217-04
Recall Event ID 27763
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD064.
Code Information Lot Numbers: T4W19H, T4WN1J.
Recalling Firm/
Manufacturer
Ethicon Endo-Surgery
4545 Creek Rd
Cincinnati OH 45242-2803
For Additional Information Contact Mr. Dirk Stevens
513-337-7501
Manufacturer Reason
for Recall
A defective articulation band may result in improper staple formation with possible hematosis.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
Quantity in Commerce 72
Distribution The product was shipped to hospitals and distributors 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.
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