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EAGLE

DEPUY SPINE, LLC · Model 286504000 · UDI-DI 10705034212746

HXW Prescription
3
510(k) clearances
320
Adverse events
3
Recalls
224
Facilities

Description

EAGLE RIGID ANTERIOR CERVICAL PLATE SYSTEM PLATE BENDER

Recalls

DateFirmReason
2021-06-30Aesculap Implant Systems LLCCustomized coronal rod benders may deform the implant when used with the spinal system devices.
2021-06-30Aesculap Implant Systems LLCCustomized coronal rod benders may deform the implant when used with the spinal system devices.
2014-12-15Synthes, Inc.Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay may occur while altern

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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.