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Tecomet

TECOMET INC. · Model 49812 · UDI-DI 00818069018924

HXW Prescription
3
510(k) clearances
320
Adverse events
3
Recalls
223
Facilities

Description

Rod Bender for 3mm & 4mm Rods

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.