ORTHOFIX GALAXY FIXATION SYSTEM 1 (REF 93410)Recalls & reported problems

Orthofix Srl · ELBOW HINGE · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18033509859533), received between Aug 6, 2026 and Aug 6, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

13 other recalls cover devices cleared under the same FDA submission (K113770); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Mechanical Problem2

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 6, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50153064 ↗
MalfunctionAug 6, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50153063 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113770. One submission often covers many models, so check the product and lot details in each record.

Z-2730-2026 · Jun 10, 2026 · Open, Classified
Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
Z-2732-2026 · Jun 10, 2026 · Open, Classified
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
Z-2731-2026 · Jun 10, 2026 · Open, Classified
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Z-2729-2026 · Jun 10, 2026 · Open, Classified
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
Z-0398-2020 · Sep 27, 2018 · Terminated
ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895
Z-0400-2020 · Sep 27, 2018 · Terminated
ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
Z-0401-2020 · Sep 27, 2018 · Terminated
ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
Z-0397-2020 · Sep 27, 2018 · Terminated
ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915
Z-0394-2020 · Sep 27, 2018 · Terminated
ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908
Z-0402-2020 · Sep 27, 2018 · Terminated
ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533
Z-0395-2020 · Sep 27, 2018 · Terminated
ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888
Z-0399-2020 · Sep 27, 2018 · Terminated
ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298
Z-0396-2020 · Sep 27, 2018 · Terminated
ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281

Device details

UDI-DI	`18033509859533`
Brand	ORTHOFIX GALAXY FIXATION SYSTEM
Model	1
Catalog no.	93410
Company	Orthofix Srl
Product code	KTT · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Class	Class 2
FDA submission	K113770
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jun 24, 2026

Device type (GMDN): External orthopaedic fixation system noninvasive component, reprocessed

A noninvasive, non-powered structural component of an external orthopaedic fixation system intended for bone/joint treatment (typically fracture stabilization, deformity correction, or distraction), in conjunction with an invasive bone pin (not included). It is in the form of a full or partial ring, rod (e.g., straight, curved, telescopic), plate, or connector (e.g., screw, bolt, nut, hinge, coupling, fastener); it is not a surgical instrument. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

Other Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component devices

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3 recalls0 reports
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Smith & Nephew, Inc. · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
145 reports
DFS HA BONE SCREWS HAA60-15020
Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 recalls0 reports
DFS HA BONE SCREWS HAA60-11030
Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 recalls0 reports
DFS HA BONE SCREWS HAB60-12040
Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 recalls0 reports
DFS HA BONE SCREWS HAA60-13040
Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 recalls0 reports
DFS HA BONE SCREWS HAA60-18030
Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 recalls0 reports
DFS HA BONE SCREWS HAA60-15030
Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 recalls0 reports

All Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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