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U.S. Department of Health and Human Services

Class 2 Device Recall ConMed Anchor Tissue Retrieval System 10 MM

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  Class 2 Device Recall ConMed Anchor Tissue Retrieval System 10 MM see related information
Date Initiated by Firm March 21, 2019
Create Date May 09, 2019
Recall Status1 Terminated 3 on January 17, 2023
Recall Number Z-1304-2019
Recall Event ID 82478
510(K)Number K172940  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX)
Catalog Number: TRS100SB2

The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.
Code Information Lot codes for product manufactured to and including the dates listed below, with the exclusions noted below for each catalog number: Beginning Manufacture Date: April 26, 2018  Beginning Lot Code: 20180426X Ending Manufacture Date: February 15, 2019  Ending Lot Code: 20190215X  Excluded Anchor Tissue Retrieval System" Lot Codes - 1. All alpha/numeric lot codes (e.g. lots 68A8T or 19A8T) 2. All numeric lot codes ending with the number 9 (e.g. Lot code 201902159)  3. All excluded numeric lot codes listed in the tables below for each specific catalog number:  Excluded Lot Codes for Cat. Number TRS100SB2: 201805095 201806055 201809265 201810314 201811224 201812114 201805144 201806115 201809285 201811054 201811234 201812124 201805145 201807134 201810014 201811064 201811264 201812144 201805194 201807245 201810094 201811074 201811274 201812174 201805214 201808155 201810154 201811084 201811284 201812184 201805255 201808164 201810164 201811124 201811304 201812204 201805284 201808165 201810184 201811134 201812034 201812214 201805295 201808205 201810194 201811144 201812044 201901024 201805315 201808214 201810224 201811154 201812054 201901034 201806015 201808225 201810234 201811164 201812064 201901044 201806045 201808234 201810244 201811204 201812074 201901074 201806054 201809255 201810254 201811214 201812104 ----- 
Recalling Firm/
Manufacturer		 Conmed Corporation
310 Broad St
Utica NY 13501-1203
For Additional Information Contact SAME as above
315-797-8375
Manufacturer Reason
for Recall		 Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
FDA Determined
Cause 2		 Process control
Action The firm, CONMED Corporation, issued an "URGENT: MEDICAL DEVICE RECALL" notification dated March 21, 2019 via USPS First Class on March 21, 2019 to its customers. The notification describes the product, problem and actions to be taken. The customers were instructed to review inventory, contact all of those departments within your facility and any other facilities that may have received affected products, complete the business reply form by fax to: 315-624-3225, Attn: Field Action Support Team, or email to: TRS2019@conmed.com, even if you do not have any affected devices to return; and return business reply form with the devices to: CONMED Corporation 525 French Road, Utica, NY 13502 USA, Return via: UPS Account # W5Y243 (no charge to your facility) Please do not return open or used devices. Questions or requests, contact the Field Action Support Team at +1-800-448-6506 (8:00am to 7:00pm EST Monday through Friday), fax to +1 315-624-3225, or email TRS2019@conmed.com.
Quantity in Commerce 69385
Distribution Worldwide Distribution: US (Nationwide) and countries of: Austria, Canada, Denmark, Great Britain, Ireland, Japan, Netherlands, OMAN, Poland, QATAR, ROMANIA, SINGAPORE, Spain and Sweden.
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 = GCJ and Original Applicant = Conmed Corporation
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