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;
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
The hazard
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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;
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1. Article Number: 9268.VIT27Model UDI-DI: 08717872031880Model 2. Article Number: 9311.27G01Model UDI-DI: 08717872035123Model 3. Article Number: 9311.27G02Model UDI-DI: 08717872035352Model 4. Article Number: 9311.27K01Model UDI-DI: N/AModel 5. Article Number: 9311.27K02Model 6. Article Number: 9311.27K03Model 7. Article Number: 9627.G0101Model 8. Article Number: 9627.G0201Model 9. Article Number: 9311.27G01-00Model UDI-DI: 08717872035321Model Lot Numbers: 202511001Model 202601070Model 51682-*-*-1Model 51683-*-*-1Model 54025-*-*-1Model 54995-*-*-1Model 56258-*-*-1UPC 08717872031880UPC 08717872035123UPC 08717872035352UPC 08717872035321Would you have heard about this one?
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