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Piccolo Composite Plate System

CARBOFIX ORTHOPEDICS LTD · Model Tibial Medial Plate, 6 holes, Left · UDI-DI 07290110207779

HRS Prescription

510(k) clearances

38,974

Adverse events (73 deaths)

287

Recalls

517

Facilities

Description

Tibial Medial plate intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.

Recalls

Date	Firm	Reason
2026-08-18	Wright Medical Technology, Inc.	Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would preve
2026-05-28	Acumed LLC	Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
2026-01-23	I.T.S. GmbH	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23	I.T.S. GmbH	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23	I.T.S. GmbH	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23	I.T.S. GmbH	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23	I.T.S. GmbH	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23	I.T.S. GmbH	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23	I.T.S. GmbH	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23	I.T.S. GmbH	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

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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.