Diamatrix Ltd.
Diamatrix · Model H568-R-D · UDI-DI 00813059018564
HNQ
Prescription
10
510(k) clearances
109
Adverse events
4
Recalls
187
Facilities
Description
Nagahara Fine Chopper & Nichamin Quick Chopper, Unique double sided instrument, Nagahara Fine Chopper, Fine interior cutting edge with blunt tip, Angled 10mm from bend to tip, & Nichamin Quick Chopper, Eye-Shaped Wedged cutting edge and Angled tip, Angled 10mm from bend to tip, Intended to be used in the right hand, Diamatrix Signature Feather-Series round handled, 134mm total length, Titanium/Stainless
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.