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DIPLOMAT MIS

SIGNUS Medizintechnik GmbH · Model Break-off instrument, tulip · UDI-DI 04047844044247

HXZ Prescription
1
510(k) clearances
510
Adverse events
1
Recalls
246
Facilities

Description

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.

Recalls

DateFirmReason
2020-11-20Zimmer Biomet, Inc.Device has the potential for fracture during use.

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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.