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Diamatrix

Diamatrix · Model H554-L-S · UDI-DI 00813059016201

HNQ Prescription
10
510(k) clearances
109
Adverse events
4
Recalls
187
Facilities

Description

Diamatrix Nucleus Chopper & Safety Quick Chopper, Unique double sided instrument, Diamatrix Nucleus Chopper Curved interior cutting edge with .5mm Olive Shaped tip, Slightly Angled 15mm from bend to tip ~ Safety Quick Chopper, .5mm Olive-Shaped Blade with 1mm bend, Angled 10mm from bend to tip, Intended to be used in the left hand, Round knurled Handle, 143mm total length, Stainless Steel

Recalls

DateFirmReason
2025-12-16Vortex 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
2025-12-16Vortex 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
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2022-03-16Carl Zeiss Meditec AGHigh friction of the slider can cause the device to stick, or not move as intended.

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Data 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.