Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint… recallZ-0622-2009 · Genico, Inc., dba Genicon · initiated Sep 25, 2008
Terminated All recalls posted in December 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Genico, Inc., dba Genicon or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Manufacturing material removal
What the company is doing
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.
Recall details
- Recall number
- Z-0622-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 25, 2008
- Posted by the FDA
- Dec 24, 2008
- Recalling firm
- Genico, Inc., dba Genicon
- Quantity
- 2,965 units (1340 OUS and 1625 US)
- Product code
- GEA
- FDA submissions
- K982472
- Distribution
- Worldwide Distribution --- including USA and countries of Africa, United Kingdom, Denmark, Colombia, Belgium, Italy, Finland, Hong Kong, and Switzerland.
Product description
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.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
3 devices cleared under K982472 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- GeniLook 200-105-152Genicon, Inc. · Cannula, Surgical, General & Plastic Surgery1 report
- Natura 210-012-151Genicon, Inc. · Cannula, Surgical, General & Plastic Surgery1 report
- Natura 210-005-152Genicon, Inc. · Cannula, Surgical, General & Plastic Surgery1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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