[pending] TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27
Pending LLM rewrite. Source: FDA_DEVICE Z-2324-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
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;
- Manufacturer
- D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- 6. Article Number: 9311.27K03
- 7. Article Number: 9627.G0101
- 8. Article Number: 9627.G0201
- 9. Article Number: 9311.27G01-00
- UDI-DI: 08717872035321
- Lot Numbers: 202511001
- 202601070
- 51682-*-*-1
- 51683-*-*-1
- 54025-*-*-1
- 54995-*-*-1
Distribution
Distributed nationwide across the United States.
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