ORTHOFIX MODULSYSTEM 1 (REF 53530)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18032568039900), received between Dec 2, 2025 and Dec 2, 2025 — classified as 1 injury.

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.

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.

• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED INFORMATION STATING THAT AN LRS ADV KIT WAS DELIVERED INCOMPLETE. AS PER REPORTER, THE SURGICAL PROCEDURE WAS COMPLETED USING OTHER ITEMS INCLUDED IN THE KIT, LEADING TO A PROLONGATION OF THE SURGERY BY 45 MINUTES. AS PER THE REPORTER, THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691661 ↗

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-0391-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955
• 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-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-0393-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979
• Z-0389-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719
• 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-0380-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603
• 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-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-0378-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)18032568031966
• 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-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-0386-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18032568861648
• 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-0390-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948

…and 8 more.