Z-0622-2009

Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792, Rx...

Name: Z-0622-2009 Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792, Rx...
Creator: Genico, Inc., dba Genicon
Published: 2008-09-25
License: https://open.fda.gov/license/

Genicon, Inc. / initiated 2008-09-25 / Terminated / root cause: manufacturing process

FDA source

Genico, Inc., dba Genicon began a recall of 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... on 2008-09-25. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0622-2009
Status: Terminated
Initiated: 2008-09-25
Posted: 2008-12-24
Terminated: 2009-01-09
Recalling firm: Genicon, Inc.
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.
Product code: GEA Cannula, Surgical, General & Plastic Surgery
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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.

Product code GEA

K982472Class IGenicon TrocarGenicon, LC / cleared 1999-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)