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U.S. Department of Health and Human Services

Class 2 Device Recall Natura

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 Class 2 Device Recall Naturasee related information
Date Initiated by FirmAugust 21, 2018
Create DateJune 05, 2020
Recall Status1 Open3, Classified
Recall NumberZ-2279-2020
Recall Event ID 85407
510(K)NumberK982472 
Product Classification Cannula, surgical, general & plastic surgery - Product Code GEA
ProductGenicon Natura Model 210-005-052, 5mm diameter, 70mm 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.
Code Information Lot I9524-A
Recalling Firm/
Manufacturer		 Genicon, Inc.
6869 Stapoint Ct Ste 112
Winter Park FL 32792-6603
For Additional Information ContactMarianne Feyas
407-657-4851
Manufacturer Reason
for Recall		There is potential for the plastic optical tip to become detached from the metal shaft.
FDA Determined
Cause 2		Process control
ActionA 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.
Quantity in Commerce0 (24 boxes with 5 units/box in inventory)
DistributionUS 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GEA
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