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Class 2 Device Recall ConMed Disposable Bipolar Ablators |
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Date Initiated by Firm |
February 01, 2021 |
Create Date |
February 26, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1155-2021 |
Recall Event ID |
87274 |
510(K)Number |
K152777 K161558
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Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product |
ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. |
Code Information |
Catalog Numbers C3390A (lots 0317F, 0417B, 0517B, 0517D, 0517J, 0617D, 0617F, 0617H, 0617K, 0717A, 0717G, 0817B, 0917G, 0917J, 1017C, 1017E, 1017J, 1117B, 0418C); C3350A (lots 0317F, 0417B, 0517B, 0517G, 0717C, 0817D, 0917C, 0917E); C3350NA (lots 0317F, 0517G, 0817F); C2455NA (lots 0317F, 0517B, 0717E, 1017C, 1017E); C1860NA (lots 0317F, 0517B, 0717E, 0817F, 1017G, 0418E); C3390NA (lots 0317F, 0517G, 0817H, 1017J, 0418E, 0518F, 1218C). |
Recalling Firm/ Manufacturer |
Bovie Medical Corporation 5115 Ulmerton Rd Clearwater FL 33760-4004
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For Additional Information Contact |
Topaz J. Kirlew 727-803-8671
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Manufacturer Reason for Recall |
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
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FDA Determined Cause 2 |
Device Design |
Action |
The firm sent "URGENT MEDICAL DEVICE RECALL" (FA-2021-1) and response form to customers on February 1, 2021. |
Quantity in Commerce |
5270 units |
Distribution |
US Nationwide distribution in the states of CA and FL. |
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 = GEI and Original Applicant = BOVIE MEDICAL CORPORATION
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