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Hallu®- LOCK

NEWDEAL · Model 299080ND · UDI-DI 10381780052029

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

Description

The right plate bender is used to bend the Hallu® Lock C plate in combination with the left plate bender in order to match the degree of dorsal flexion required by the case or by the activity of the patient.

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.