Recall Z-1309-2019 ยท GCJ Laparoscope, General & Plastic Surgery
Conmed Corporation
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.
| Date | Mar 21, 2019 |
| Status | Terminated |
| Reason | Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product |
| 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: TRS2019@conmed.com, even if you do not have any affected devices to return; and return |
| Quantity | 7930 |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of: Austria, Canada, Denmark, Great Britain, Ireland, Japan, Netherlands, OMAN, Poland, QATAR, ROMANIA, SINGAPORE, Spain and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172940 | ANCHOR Tissue Retrieval System Conmed Corporation, Oct 18, 2017 |