Recall Z-0622-2009 ยท GEA Cannula, Surgical, General & Plastic Surgery
Genico, Inc., dba Genicon
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.
| Date | Dec 24, 2008 (initiated Sep 25, 2008) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982472 | GENICON TROCAR Genicon, LC, Feb 4, 1999 |