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.
This recall has been terminated (originally issued December 24, 2008).
- Company
- Genico, Inc., Dba Genicon
- Recall Initiated
- September 25, 2008
- Posted
- December 24, 2008
- Terminated
- January 9, 2009
- Recall Number
- Z-0622-2009
- Quantity
- 2,965 units (1340 OUS and 1625 US)
- Firm Location
- Winter Park, FL
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution --- including USA and countries of Africa, United Kingdom, Denmark, Colombia, Belgium, Italy, Finland, Hong Kong, and Switzerland.
Lot / Code Info
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.
Root 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.