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U.S. Department of Health and Human Services

Class 2 Device Recall CORE Trumpet Handpiece only

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  Class 2 Device Recall CORE Trumpet Handpiece only see related information
Date Initiated by Firm June 27, 2016
Create Date October 18, 2016
Recall Status1 Terminated 3 on June 07, 2018
Recall Number Z-0135-2017
Recall Event ID 74774
510(K)Number K926477  
Product Classification Catheter, peritoneal - Product Code GBW
Product CORE¿ Trumpet Handpiece only, Catalog Number CD8450
The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
Code Information Beginning Lot Code 110609X to Ending Lot Code 20160308X
Recalling Firm/
Manufacturer		 ConMed Corporation
525 French Rd
Utica NY 13502-5945
Manufacturer Reason
for Recall		 The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
FDA Determined
Cause 2		 Under Investigation by firm
Action ConMed sent an Urgent Device Recall letter dated June 27, 2016, to all affected customers with reply forms via USP First Class Mail. International customers received a notice dated July 11, 2016 by courier service. Customers were advised to inspect their inventory for any of the devices subject to recall. Customers were urged to contact all departments within their facility and any other facilities within their organization that may have received affected products. It is imperative that all end users of these devices receive the notification. Customers who have received any of the affected product are asked to complete and return the reply form along with the device to: CONMED Corporation 525 French Road Utica, NY 13502 USA Attn: Ed Kovac. Please do not return used devices. Replacement product will be issued unless otherwise requested. If customers do not have any affected devices to return, complete and return the business reply form indicating they have no devices and return by one of the means listed:1. Email to: coresihp@conmed.com 2. Fax to: Field Action Support Team at 315-624-3225. 3. US mail, using enclosed postage-paid envelope, to: CONMED, 525 French Road, Utica, NY 13502; Attn: Field Action Support Team. Customers with questions or requests, should contact the Field Action Support Team at 315-624-3237, fax to 315-624-3225, or email coresihp@conmed.com.
Distribution Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GBW and Original Applicant = CORE DYNAMICS, INC.
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