Device product
TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00;
Z-2324-2026
Product summary
- Event
- Event 98814
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 261 boxes totaling 1566 units
- Official record key
device-enforcement:Z-2324-2026
Official wording
Reason: An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Code information: 1. Article Number: 9268.VIT27; UDI-DI: 08717872031880; 2. Article Number: 9311.27G01; UDI-DI: 08717872035123; 3. Article Number: 9311.27G02; UDI-DI: 08717872035352; 4. Article Number: 9311.27K01; UDI-DI: N/A; 5. Article Number: 9311.27K02; UDI-DI: N/A; 6. Article Number: 9311.27K03; UDI-DI: N/A; 7. Article Number: 9627.G0101; UDI-DI: N/A; 8. Article Number: 9627.G0201; UDI-DI: N/A; 9. Article Number: 9311.27G01-00; UDI-DI: 08717872035321; Lot Numbers: 202511001, 202601070, 51682-*-*-1, 51683-*-*-1, 54025-*-*-1, 54995-*-*-1, 56258-*-*-1, 56259-*-*-1, 64307-*-*-1, 64310-*-*-1, 69018-*-*-1, 75718-*-*-1, 76781-*-*-1, 76810-*-*-1, 77842-*-*-1, 79461-*-*-1, 80339-*-*-1, 80964-*-*-1, 81336-*-*-1, 82214-*-*-1, 82743-*-*-1, 83585-*-*-1, 84581-*-*-1, 85452001, 86070001, 87206001, 90383001, 97231001;
Distribution pattern: Worldwide - US Nationwide and the countries of AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CZECHIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, IRELAND, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, TURKEY.
Derived failure modes
-
Unknown
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.