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Surgical Instrument

OSTEONIC CO.,Ltd. · Model Y1J.35010 · UDI-DI 08809539697369

HXP Prescription
5
510(k) clearances
156
Adverse events
1
Recalls
158
Facilities

Recalls

DateFirmReason
2013-06-22Synthes USA HQ, Inc.A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.