Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792, Rx Only. Cata
FDA device recall Z-0622-2009 · posted 2008-12-24 · Terminated
Recall details
- Recalling firm
- Genico, Inc., dba Genicon
- 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.
- 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.
- Root cause
- Manufacturing material removal
- Status
- Terminated
- Product code
- GEA
- Quantity affected
- 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.
- Date initiated
- 2008-09-25
- Date posted
- 2008-12-24
- Date terminated
- 2009-01-09
- Location
- Winter Park, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENICON TROCAR (K982472) | Genicon, LC | 1999-02-04 |