ORTHOFIX GALAXY FIXATION SYSTEM 1 (REF 93432)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18033509859212), received between Jul 3, 2018 and Jul 3, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Jam” (1 report).

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2018Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: DR. (B)(6). DATE OF INITIAL SURGERY: ON (B)(6) 2018 BODY PART TO WHICH DEVICE WAS APPLIED: ELBOW/ULNA. PATIENT INFORMATION: 30 YEAR OLD, MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: THE BALL JOINT OF THE ULNA DISTRACTION CLAMP (93432) WAS LOCKED. LATER DURING THE SURGERY THE BALL JOINT IN THESE CLAMP WAS BLOCKING SO THAT IS WAS NOT POSSIBLE TO INSERT THE SPHERICAL CYLINDER AND THE BRACING ANY MORE. IT WAS NOT ABLE TO GO ON WITH THE INTRAOPERATIVE ELBOW DISTRACTION FOR THE SURGEON. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A GALAXY ELBOW FIXATOR WAS USED TO COMPLETE THE SURGERY. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: EXTRA ANESTHESIA. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE XRAY IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITION: LACK OF FLEXION (100

  Patient problems: No Code Available

  MAUDE report 7657668 ↗

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-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-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-0397-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915
• Z-0401-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
• 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