Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ConMed Disposable Bipolar Ablators

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall ConMed Disposable Bipolar Ablatorssee related information
Date Initiated by FirmFebruary 01, 2021
Create DateFebruary 26, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1155-2021
Recall Event ID 87274
510(K)NumberK152777 K161558 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductConMed 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
For Additional Information ContactTopaz J. Kirlew
727-803-8671
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.
FDA Determined
Cause 2		Device Design
ActionThe firm sent "URGENT MEDICAL DEVICE RECALL" (FA-2021-1) and response form to customers on February 1, 2021.
Quantity in Commerce5270 units
DistributionUS Nationwide distribution in the states of CA and FL.
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 = GEI
-
-