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U.S. Department of Health and Human Services

Class 2 Device Recall GENILook

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  Class 2 Device Recall GENILook see related information
Date Initiated by Firm August 21, 2018
Create Date June 05, 2020
Recall Status1 Open3, Classified
Recall Number Z-2271-2020
Recall Event ID 85407
510(K)Number K982472  
Product Classification Cannula, surgical, general & plastic surgery - Product Code GEA
Product Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - 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 I7781-C
Recalling Firm/
Manufacturer		 Genicon, Inc.
6869 Stapoint Ct Ste 112
Winter Park FL 32792-6603
For Additional Information Contact Marianne 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
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.
Quantity in Commerce 12 boxes (5 units per box)
Distribution 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
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = GEA and Original Applicant = GENICON, LC
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