Recall Z-1307-2019— Conmed Corporation

Class II · Terminated

Class II FDA medical device recall by Conmed Corporation, initiated 2019-03-21, terminated 2023-01-17. It names one FDA 510(k) clearance: K172940. Product: ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 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.. Reason: Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product.

Recalling firm
Conmed Corporation
Classification
Class II
Status
Terminated
Initiated
2019-03-21
Terminated
2023-01-17
Firm location
Utica, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.