Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
FDA Recall Z-2275-2020 · Posted None
Advertisement
Recalling FirmGenicon, Inc.
Recall StatusOpen, Classified
Product CodeGEA
Date Initiated2018-08-21
Product Quantity102 boxes (5 units per box)
Reason for Recall
There is potential for the plastic optical tip to become detached from the metal shaft.
Firm Action
A customer letter will be issued to impacted customers during the week of 5/25/2020. Customers are asked to inspect their inventory for impacted lots and return the devices to Genicon.
Customers may contact Mr. Justin Colon, Genicon Customer Service on Mon-Thurs 9am-4pmEST at 407-657-4851, extension #800.
Root Cause
Process control
Distribution Pattern
US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement