PREFIX FIXATOR 1 (REF 92011)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18032568867220), received between Jan 24, 2020 and Jan 24, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2020Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - DEVICES CODE: SEVEN DEVICES CODE 92015 (SCREW CLIP CLAMP) AND THREE DEVICES CODE 92011 (ROD CLIP CLAMP). - BATCH NUMBERS: B1357393 (QTY 2) - B1351455 (QTY 2) - B1357338 (QTY 1) - B1285509 (QTY 1) - B1266743 (QTY 1) - B1304019 (QTY 2) - B1282257 (QTY 1). - TOTAL QUANTITY: TEN (MFR REPORTS FROM 9680825-2020-00001 TO 9680825-2020-00010 REFLECTING THE SEQUENCE OF THE BATCH NUMBERS LISTED ABOVE). - HOSPITAL NAME: (B)(4) EMERGENCY MEDICAL CENTER (SOUTH DISTRICT). - SURGEON NAME: (B)(6). - DATE OF INITIAL SURGERY: NOT PROVIDED. - BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA FRACTURE. - SURGERY DESCRIPTION: FRACTURE TREATMENT. - PATIENT INFORMATION: (B)(6) YEARS, MALE, IN GOOD HEALTH CONDITION. - PROBLEM OBSERVED DURING: ON SCHEDULED DEVICE REMOVAL - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: "TIBIA FRACTURE WAS CAUSED BY TRAFFIC ACCIDENT INJURY, AND THEN EXTERNAL FIXATION WAS PERFORMED. ABOUT ONE WEEK AFTER FIXATION, THE PATIENT AND THE DOCTOR FOUND THAT PREFIX ROD CLAMP WERE BROKEN, RESULTING IN A DECREASE IN STABILITY". THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS O

  Patient problems: No Code Available

  MAUDE report 9626997 ↗
• InjuryJan 24, 2020Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: SEVEN DEVICES CODE 92015 (SCREW CLIP CLAMP) AND THREE DEVICES CODE 92011 (ROD CLIP CLAMP). BATCH NUMBERS: B1357393 (QTY 2) - B1351455 (QTY 2) - B1357338 (QTY 1) - B1285509 (QTY 1) - B1266743 (QTY 1) - B1304019 (QTY 2) - B1282257 (QTY 1). TOTAL QUANTITY: TEN (MFR REPORTS FROM 9680825-2020-00001 TO 9680825-2020-00010 REFLECTING THE SEQUENCE OF THE BATCH NUMBERS LISTED ABOVE). HOSPITAL NAME: (B)(6). SURGEON NAME: DR (B)(6). DATE OF INITIAL SURGERY: NOT PROVIDED. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA FRACTURE. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: (B)(6) YEARS, MALE, IN GOOD HEALTH CONDITION. PROBLEM OBSERVED DURING: ON SCHEDULED DEVICE REMOVAL. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "TIBIA FRACTURE WAS CAUSED BY TRAFFIC ACCIDENT INJURY, AND THEN EXTERNAL FIXATION WAS PERFORMED. ABOUT ONE WEEK AFTER FIXATION, THE PATIENT AND THE DOCTOR FOUND THAT PREFIX ROD CLAMP WERE BROKEN, RESULTING IN A DECREASE IN STABILITY". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (ADVERSE EFFECTS NOT SPECIFIED). THE INITIAL SURGERY W

  Patient problems: No Code Available

  MAUDE report 9626996 ↗
• InjuryJan 24, 2020Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: SEVEN DEVICES CODE 92015 (SCREW CLIP CLAMP) AND THREE DEVICES CODE 92011 (ROD CLIP CLAMP). BATCH NUMBERS: B1357393 (QTY 2) - B1351455 (QTY 2) - B1357338 (QTY 1) - B1285509 (QTY 1) - B1266743 (QTY 1) - B1304019 (QTY 2) - B1282257 (QTY 1). TOTAL QUANTITY: TEN (MFR REPORTS FROM 9680825-2020-00001 TO 9680825-2020-00010 REFLECTING THE SEQUENCE OF THE BATCH NUMBERS LISTED ABOVE). HOSPITAL NAME: (B)(6). SURGEON NAME: DR (B)(6). DATE OF INITIAL SURGERY: NOT PROVIDED. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA FRACTURE. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: (B)(6) YEARS, MALE, IN GOOD HEALTH CONDITION. PROBLEM OBSERVED DURING: ON SCHEDULED DEVICE REMOVAL. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "TIBIA FRACTURE WAS CAUSED BY TRAFFIC ACCIDENT INJURY, AND THEN EXTERNAL FIXATION WAS PERFORMED. ABOUT ONE WEEK AFTER FIXATION, THE PATIENT AND THE DOCTOR FOUND THAT PREFIX ROD CLAMP WERE BROKEN, RESULTING IN A DECREASE IN STABILITY". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (ADVERSE EFFECTS NOT SPECIFIED). THE INITIAL SURGERY W

  Patient problems: No Code Available

  MAUDE report 9626995 ↗

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-0389-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719
• 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-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-0388-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791
• 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-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-0387-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696
• 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-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-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
• 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-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-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-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

…and 8 more.