| Class 2 Device Recall GENICON EZEE | |
Date Initiated by Firm | July 19, 2017 |
Create Date | March 16, 2018 |
Recall Status1 |
Terminated 3 on May 18, 2020 |
Recall Number | Z-1076-2018 |
Recall Event ID |
78655 |
510(K)Number | K162059 |
Product Classification |
Laparoscope, general & plastic surgery - Product Code GCJ
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Product | GENICON EZEE Retrieval, sterile, Rx only. |
Code Information |
Catalog No. 550-000-000; Lot No. I8095/2017-11-08, I8162-2018-01-09, I8162/2020-01-09; UDI: 00877972005223. |
Recalling Firm/ Manufacturer |
Genicon, Inc. 6869 Stapoint Ct Ste 112 Winter Park FL 32792-6603
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For Additional Information Contact | 407-657-4851 |
Manufacturer Reason for Recall | Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use. |
FDA Determined Cause 2 | Device Design |
Action | Consignees were notified via email on 07/19/2017. Instructions included |
Quantity in Commerce | 2,967 units |
Distribution | Distributed domestically to FL, IL, MI, TN, UT.
Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom. |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = GCJ
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