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MEDLINEUNITE

MEDLINE INDUSTRIES, INC. · Model MPPF1110 · UDI-DI 10888277364448

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

Description

PIN, TEMP FIX, SMOOTH, 1.1 X 10MM

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.