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Terminated

ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number: TRS-ROBO-12 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.

FDA Recall Z-1309-2019 · Posted None

Recalling FirmConmed Corporation
Recall StatusTerminated
Product CodeGCJ
Date Initiated2019-03-21
Date Terminated2023-01-17
Product Quantity7930

Reason for Recall

Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product

Firm 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].

Root Cause

Process control

Distribution Pattern

Worldwide Distribution: US (Nationwide) and countries of: Austria, Canada, Denmark, Great Britain, Ireland, Japan, Netherlands, OMAN, Poland, QATAR, ROMANIA, SINGAPORE, Spain and Sweden.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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