Diamatrix
Diamatrix · Model H439-AR-S · UDI-DI 00813059014634
HNQ
Prescription
10
510(k) clearances
109
Adverse events
4
Recalls
188
Facilities
Description
Diamatrix Nucleus Chopper, Angled, Curved interior cutting edge with .5mm olive shaped tip, Intended to be used in the right hand, Slightly Angled 15mm from bend to tip, Round knurled Handle, 117mm total length, Stainless Steel
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-16 | Vortex Surgical Inc. | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination |
| 2025-12-16 | Vortex Surgical Inc. | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination |
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2022-03-16 | Carl Zeiss Meditec AG | High friction of the slider can cause the device to stick, or not move as intended. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.