Z-1305-2019Class II

ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS175SB2 The Anchor Tissue...

Name: Z-1305-2019 ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS175SB2 The Anchor Tissue...
Creator: Conmed Corporation
Published: 2019-03-21
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2019-03-21 / Terminated / root cause: manufacturing process

FDA source

Conmed Corporation began a recall of 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... on 2019-03-21. FDA classified it as Class II and gives the reason as "Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1305-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-21
Posted: 2019-05-09
Terminated: 2023-01-17
Recalling firm: ConMed Corporation
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.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
Root cause tag: manufacturing process
FDA root 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: [email protected], 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 [email protected].
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1305-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1304-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-09
Z-1305-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-09
Z-1306-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-09
Z-1307-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-09
Z-1308-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-09
Z-1309-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-09

Product code GCJ

K172940Class IIANCHOR Tissue Retrieval SystemConmed Corporation / cleared 2017-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)