ORTHOFIX MODULSYSTEM 1 (REF M101)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18032568866636), received between Feb 6, 2025 and Feb 6, 2025 — classified as 2 injuries.

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

1 FDA recall record name this device's identifier, 1 still open.

23 other recalls cover devices cleared under the same FDA submission (K955848); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 10, 2026Open, Classified

   Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

   Z-2729-2026 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

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

• InjuryFeb 6, 2025Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6), SURGEON'S NAME: DR. (B)(6), DATE OF INITIAL SURGERY: ON (B)(6) 2024, BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT ULNA, SURGERY DESCRIPTION: ULNA LENGTHENING, PATIENT INFORMATION: 21-YEAR-OLD, FEMALE, PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE, TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM, EVENT DESCRIPTION: FAMILY STATED RAIL FELL OFF AT HOME DURING LENGTHENING. RAIL AND PINS DO NOT LOOK COMPROMISED. ANOTHER SURGERY WILL NEED TO BE PERFORMED. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF LENGTH AND CORRECTION THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE AN ADDITIONAL SURGERY IS REQUIRED: TO BE DEFINED A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED: PERFORMED ON (B)(6) 2025. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE THE DEVICE WAS AT ITS FIRST USE PATIENT CURRENT HEALTH CONDITION: N/A MANUFACTURER REFERENCE NUMBER: (B)(4) DISTRIBUTOR REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322936 ↗
• InjuryFeb 6, 2025Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6), SURGEON'S NAME: DR. (B)(6), DATE OF INITIAL SURGERY: (B)(6), 2024 BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT ULNA, SURGERY DESCRIPTION: ULNA LENGTHENING, PATIENT INFORMATION: 21-YEAR-OLD, FEMALE, PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE, TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM, EVENT DESCRIPTION: FAMILY STATED RAIL FELL OFF AT HOME DURING LENGTHENING. RAIL AND PINS DO NOT LOOK COMPROMISED. ANOTHER SURGERY WILL NEED TO BE PERFORMED. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF LENGTH AND CORRECTION THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE AN ADDITIONAL SURGERY IS REQUIRED: TO BE DEFINED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED: PERFORMED ON (B)(6) 2025. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. THE DEVICE WAS AT ITS FIRST USE. PATIENT CURRENT HEALTH CONDITION: PINS OF THE MINIRAIL WERE REMOVED AND PATIENT HAD INTERNAL FIXATION AND BONE GRAFT. MANUFACTURER REFERENCE NUMBER: (B)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21320392 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K955848. One submission often covers many models, so check the product and lot details in each record.

• Z-0387-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696
• Z-0393-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979
• Z-0381-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856068
• Z-0374-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120
• Z-0385-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918
• Z-0375-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
• Z-0382-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075
• Z-0383-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099
• Z-0384-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901
• Z-0377-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911
• Z-0392-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 18033509855962
• Z-0373-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959
• Z-0379-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137
• Z-0376-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
• Z-0388-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791

…and 8 more.