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U.S. Department of Health and Human Services

Class 2 Device Recall Verspoint

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  Class 2 Device Recall Verspoint see related information
Date Initiated by Firm December 16, 2004
Date Posted February 02, 2005
Recall Status1 Terminated 3 on October 31, 2005
Recall Number Z-0493-05
Recall Event ID 30711
510(K)Number K962482  
Product Classification Hysteroscope (And Accessories) - Product Code HIH
Product VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc., a Johnson & Johnson Company, Somerville, NJ 08876. The product subject of this recall is the connector cable which goes between the electrosurgical generator and the elctrode used for surgery. Specifically, the recall focuses on the hand grip on the electrode, formed by overmolding a polymer onto the cable, which deforms upon sterilization.
Code Information Product Code: 00480; Lot #s:  0404086, 0404121, 0404152, 0405010, 0405123, 0406014, 0406068, 0406130, 0407104, 0408031, 0409029, 0409080, 0410021, 0410103, 0411040.
Recalling Firm/
Manufacturer		 Ethicon, Inc
US Highway 22 West
Somerville NJ 08876
For Additional Information Contact William Goeller
908-218-2651
Manufacturer Reason
for Recall		 Deformation of the Verspoint Hysteroscopic System Connector Cable hand grips when autoclaved causing possible non-sterile electrodes.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recall letter was mailed to the Director of Material Management and the Director of Operating Room on December 14, 2004.
Quantity in Commerce 891electrodes
Distribution Ethicon distributed the devices to 166 hospitals in the US. There are no Government sales. Product sold to other countries was distributed directly from the manufacturerin England to Ethicon distributors outside the US. The Foreign countries with accounts are: Austria, Czech Republic, Greece, Italy, Benelux, Poland, Portugal, Slovenia, Spain, Sweden, France, Germany, Ireland, U.K. Canada, China, Mexico, Taiwan, Venezuela, Korea, Australia, Brazil, and India.
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 = HIH and Original Applicant = GYNECARE, INC.
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