| Class 2 Device Recall GENILook | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GEA
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