D.O.R.C. TDC VELOCE 27G Two Dimensional Cutter recalled for loose outer knife
The outer knife on certain D.O.R.C. TDC VELOCE 27G surgical cutters may become loose during use. This surgical device is used in ophthalmic (eye) procedures, and a loose knife could affect device performance.
From the FDA notice · Read the official notice ↗
What to do
- Check your TDC VELOCE 27G cutter against the recalled article numbers and lot numbers listed
- Contact your device supplier or D.O.R.C. for instructions on inspection, repair, or replacement
- Do not use affected units until you have received guidance from the manufacturer
Is yours affected?
Compare your label or packaging with the recalled product.
- 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;
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 261 boxes totaling 1566 units
- Illnesses reported
- None reported
- Manufactured in
- Scheijdelveweg 2, N/A, Zuidland, N/A, Netherlands
- Classification
- Class II
- Recall number
- Z-2324-2026
In the FDA's words
- Description
- 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; An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. 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: 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. Affected quantity: 261 boxes totaling 1566 units
- Hazard
- An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
3 products in this recall
The agency lists each product separately. Check every one you might have.
- TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311.23K02, 9311.23K03, 9623.G0201, 9623…Z-2322-2026 · 314 boxes, totaling 1884 units
- TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;Z-2323-2026 · 2068 boxes totaling 12408 units
- 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… (this page)Z-2324-2026 · 261 boxes totaling 1566 units