Recall Z-0622-2009
Genico, Inc., dba Genicon · initiated September 25, 2008
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.
Codes / 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.
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: Manufacturing material removal
Action taken
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.
Details
- Recall number
- Z-0622-2009
- Initiated
- September 25, 2008
- Posted by FDA
- December 24, 2008
- Terminated
- January 9, 2009
- Product code
- GEA – Cannula, Surgical, General & Plastic Surgery
- Quantity
- 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.
- Recalling firm
- Genico, Inc., dba Genicon, Winter Park, FL