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U.S. Department of Health and Human Services

Class 2 Device Recall 5mm Pyramidal Trocar

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  Class 2 Device Recall 5mm Pyramidal Trocar see related information
Date Initiated by Firm September 25, 2008
Date Posted December 24, 2008
Recall Status1 Terminated 3 on January 09, 2009
Recall Number Z-0622-2009
Recall Event ID 50489
510(K)Number K982472  
Product Classification General & Plastic Surgery Surgical Cannula - Product Code GEA
Product Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792, Rx Only. Catalog Numbers: 100-005-001 & 100-005-002.

Used for incisions made for positioning the laparoscopic cannulas or ports.
Code Information Lot # I1219-K, exp: 11/01/2012; I1220-K, exp: 11/01/2012; I1278-K, exp: 01/01/2013; I1281-K, exp: 01/01/2013; I1393-K, exp: 03/01/2013; I1394-K, exp: 03/01/2013; I1415-K, exp: 03/01/2013; I1423-K, exp: 03/01/2013; I1487-K, exp: 04/01/2013; I1470-K, exp: 04/01/2013; and I1471-K, exp: 04/01/2013.
Recalling Firm/
Manufacturer		 Genico, Inc., dba Genicon
6869 Stapoint Ct Ste 114
Winter Park FL 32792-6603
For Additional Information Contact
407-657-4851
Manufacturer Reason
for Recall		 The stainless steel tips on the Genicon 5mm Pyramidal Trocar exhibited contamination that resembled rust and there was also pitting on the tip of the trocar.
FDA Determined
Cause 2		 Manufacturing material removal
Action Consignees were notified with a letter, dated 9/19/2008, by e-mail and fax on 09/25/2008. The letter stated a description of the issue, analysis and reliability data, indications of Device Malfunction, and recommendations. There was also a request for all defective devices to be returned to the distributor or Genicon for replacement. Genicon Customer service was to be contacted at 407-657-4851.
Quantity in Commerce 2,965 units (1340 OUS and 1625 US)
Distribution Worldwide Distribution --- including USA and countries of Africa, United Kingdom, Denmark, Colombia, Belgium, Italy, Finland, Hong Kong, and Switzerland.
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 = GEA and Original Applicant = GENICON, LC
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