Class 2 Device Recall ConMed Anchor Tissue Retrieval System 15 MM

• Date Initiated by Firm: March 21, 2019
• Create Date: May 09, 2019
• Recall Status: Terminated on January 17, 2023
• Recall Number: Z-1305-2019
• Recall Event ID: 82478
• 510(K)Number: K172940
• Product Classification: Laparoscope, general & plastic surgery - Product Code GCJ
• Product: ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX); Catalog Number: TRS175SB2; ; 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 TRS175SB2: 201808025 201809215 201901164 201901184 201901224 201809205 201901154 201901174 201901214
• 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: 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: 11835
• 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