D.O.R.C. TDC VELOCE 23G surgical cutter recalled for loose outer knife
D.O.R.C. has recalled certain TDC VELOCE 23G Two Dimensional Cutters used in ophthalmic surgery because the outer knife can become loose during use. An increased number of complaints about this issue prompted the recall. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- If you use or manage affected units (check article numbers 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01–K03, 9623.G0201, 9623.G0202, 9623.K0201, or 9311.23G01-00), stop using them immediately.
- Contact D.O.R.C. or your supplier for instructions on replacement or return.
- Verify the lot number on your units against the recall list to confirm whether they are affected.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.G0202, 9623.K0201, 9311.23G01-00;
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 314 boxes, totaling 1884 units
- Illnesses reported
- None reported
- Manufactured in
- Scheijdelveweg 2, N/A, Zuidland, N/A, Netherlands
- Classification
- Class II
- Recall number
- Z-2322-2026
In the FDA's words
- Description
- 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.G0202, 9623.K0201, 9311.23G01-00; 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.VIT23; UDI-DI: 08717872031866; 2. Article Number: 9311.23G01; UDI-DI: 08717872035109; 3. Article Number: 9311.23G02; UDI-DI: 08717872035338; 4. Article Number: 9311.23K01; UDI-DI: N/A; 5. Article Number: 9311.23K02; UDI-DI: N/A; 6. Article Number: 9311.23K03; UDI-DI: N/A; 7. Article Number: 9623.G0201; UDI-DI: N/A; 8. Article Number: 9623.G0202; UDI-DI: N/A; 9. Article Number: 9623.K0201; UDI-DI: N/A; 10. Article Number: 9311.23G01-00; UDI-DI: 08717872035307; Lot Numbers: 100637001, 57682-*-*-1, 64312-*-*-1, 69017-*-*-1, 73237-*-*-1, 74225-*-*-1, 75735-*-*-1, 79460-*-*-1, 80338-*-*-1, 80963-*-*-1, 81335-*-*-1, 81679-*-*-1, 82213-*-*-1, 82325-*-*-1, 82742-*-*-1, 82779-*-*-1, 83584-*-*-1, 84580-*-*-1, 85451001, 86069001, 86798001, 86799001, 87205001, 88231001, 91957001, 92629001, 92630001, 93336001, 94351001, 95436001, 95462001, 96097001, 96123001, 97279001, 97789001, 98643001, 99130001, 99185001, 99697001; 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: 314 boxes, totaling 1884 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… (this page)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…Z-2324-2026 · 261 boxes totaling 1566 units