Recall Z-1465-2023 ยท GCJ Laparoscope, General & Plastic Surgery
Covidien LP
VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
| Date | Apr 26, 2023 (initiated Mar 22, 2023) |
| Status | Open, Classified |
| Reason | There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together. |
| Root cause | Process control |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated March 2023 was sent to customers. Customer Actions: Our records show that your facility has received the impacted product. Medtronic requests that you take the following actions: " Identify and quarantine any used and unused impacted product. Please refer to Attachment A: Impacted Serial Number Lists for a list of affected products. For verifying the respective product and serial number on the device and packaging please refer to Attachment B. " Sterilize all used devices as per your standard decontamination protocol prior to returning |
| Quantity | 1 units |
| Distribution | Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201805 | VersaOne Reusable Positioning Trocar System Covidien, Aug 26, 2020 |