Recall Z-2243-2024 ยท HRX Arthroscope
WOM World Of Medicine AG
WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01
| Date | Jul 1, 2024 (initiated May 24, 2024) |
| Status | Open, Classified |
| Reason | Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery |
| Root cause | Process control |
| Action | Smith & Nephew Issued Urgent Field Safety Notice (FSN) - MEDICAL DEVICE RECALL WOM reference no.: 2024-0001 via email on 5/24/23. Letter states reason fo recall, health risk and action to take; lnform individuals within your organization who need to be aware of this recall. - Check all stock areas and/or operating room storage to determine if any tube sets with lol numbers from Annex 'l are at your facility, - Dispose of all affected tube sets properly. Confirm this on the customer response form. Return the form to fieldactions@smith-nephew.com. Please send any questions to fieldactions@smi |
| Quantity | 1700 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062380 | FLOSIMPLE ARTHROSCOPY PUMP A120 W.O.M. World of Medicine AG, Dec 14, 2006 |