SELF CENTERING 2055-13-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 324 adverse event reports that list this exact device (DI 10603295084488), received between Sep 15, 2017 and Sep 21, 2026 — classified as 2 injuries, 322 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (132 reports).

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 25 most recent of 324 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845881 ↗
• MalfunctionSep 18, 2026Device-Device Incompatibility; Mechanical Jam

  It was reported that during trialing for the unipolar ball the scrub tech had difficulty applying the mod endo head trial to the handle. It eventually went on but was difficult to remove after the surgery when instruments were returned to their trays. After decontamination the reporter found one or two perimeter ball bearings did not fully depress. The reporter soaked the handle in a milk/lubricant recommended by the hospital's SPD director, which did not resolve the problem. The issue did not cause delay to the surgery. The head trial was not affected. The instrument was removed from use. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820270 ↗
• MalfunctionSep 3, 2026Device-Device Incompatibility; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50596582 ↗
• MalfunctionMay 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE BIPOLAR HEAD TRIAL WON'T COME OFF ANGLED INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230819 ↗
• MalfunctionMay 18, 2026Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING WASHING OF THE SELF-CENTERING MODULAR CATHCART HANDLE ANGLED DEVICE, BROWN FLUID LEAKED FROM THE END. WATER HAD LIKELY ENTERED UNDER THE BALL BEARINGS AND CAUSED RUST. NO DELAYS OCCURRED DURING THE HIP SURGERY. NO PATIENT INJURIES OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25204762 ↗
• MalfunctionMay 14, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, ONE OF THE BALL BEARINGS WAS STUCK AND THE TRIAL DOES NOT GO ON THE HANDLE. NO DELAYS DURING DURING THE CASE AND NO PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176604 ↗
• MalfunctionMay 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE HOSPITAL FOUND BIOBURDEN IN ALL OF THEIR BIPOLAR ENDO HEAD TRIAL HANDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092874 ↗
• MalfunctionMay 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE HOSPITAL FOUND BIOBURDEN IN ALL OF THEIR BIPOLAR ENDO HEAD TRIAL HANDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092813 ↗
• MalfunctionMay 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE HOSPITAL FOUND BIOBURDEN IN ALL OF THEIR BIPOLAR ENDO HEAD TRIAL HANDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092797 ↗
• MalfunctionMay 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE HOSPITAL FOUND BIOBURDEN IN ALL OF THEIR BIPOLAR ENDO HEAD TRIAL HANDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092767 ↗
• MalfunctionApr 2, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE SPRING MECHANISM IN THE DEVICES HOLDS BIO BURDEN, RESULTING IN THE FACILITY'S DECISION TO DISCONTINUE STERILIZATION BY SPD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769127 ↗
• MalfunctionMar 19, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE HANDLE CAN NO LONGER BE CLEANED. BLOOD GETTING CAUGHT BEHIND THE BEARINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640746 ↗
• MalfunctionMar 3, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THEY WERE DOING A HEMI. THE CURVED WHITE HANDLE THAT ATTACHES TO THE HEMI TRIALS WAS TOUGH TO GET ON AND OFF. THIS DID NOT SLOW THE SURGERY DOWN AND THE SURGERY PROCEEDED AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494668 ↗
• MalfunctionFeb 23, 2026Contamination /Decontamination Problem

  IT WAS REPORTED BEHIND THE INSTRUMENTS` SPRING BALLS BLOOD, FLUID, TISSUE, ETC. IS STILL APPARENT AFTER REPROCESSING. INSTRUMENT IS NOT POSSIBLE TO BE REPROCESSED PROPERLY. NO ADVERSE PATIENT IMPACT, NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421026 ↗
• MalfunctionFeb 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT S/C TRIAL HANDLE AND S/C TRIAL HANDLE ANGLED WERE DUE TO AN INABILITY TO DISASSEMBLE THE INSTRUMENTS, WHICH PREVENTED CLEANING BEHIND THE SPRING BALLS. THE EVENT WAS IDENTIFIED IN THE CENTRAL STERILE SERVICES DEPARTMENT, AND THE CUSTOMER DECLINED TO REPROCESS THE INSTRUMENTS. THERE WAS NO ADVERSE PATIENT IMPACT OR SURGICAL DELAY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400196 ↗
• MalfunctionFeb 19, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT AFTER THE SURGICAL PROCEDURE, BEHIND THE INSTRUMENTS SPRING BALLS BLOOD, FLUID, TISSUE, WERE STILL APPARENT AFTER REPROCESSING. THE INSTRUMENT WAS NOT POSSIBLE TO BE REPROCESSED PROPERLY. NO ADVERSE PATIENT IMPACT, NO SURGICAL DELAY REPORTED. S/C TRIAL HANDLE ANGLED: 205513000: NOT APPLICABLE. LIST ANY J&J PRODUCTS THAT WERE UTILIZED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. WAS THERE ANY REPORTED PATIENT OR USER HARM? NO. WAS THERE A SIGNIFICANT DELAY? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393169 ↗
• MalfunctionFeb 18, 2026Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING STERILE PROCESSING IT WAS OBSERVED THAT THE HANDLE WAS HOLDING BIO BURDEN AND RUST IN THE ATTACHMENT PIECE FOR THE HEAD TRIALS AND COULD NOT BE CLEANED PROPERLY. THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384657 ↗
• MalfunctionFeb 13, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT IT DID NOT HAPPEN IN SURGERY, SPD FOUND DEBRIS COMING OUT OF THE LOCKING MECHANISM AND CANNOT BE CLEANED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333262 ↗
• MalfunctionFeb 12, 2026Device-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENT WAS NOT HOLDING PROPERLY DUE TO WEAR. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321691 ↗
• MalfunctionFeb 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT IT IS VERY DIFFICULT TO GET THE MOD ENDO HEAD TRIALS ON AND OFF THE WHITE HANDLE, AS THEY TEND TO GET STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270603 ↗
• MalfunctionJan 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLES DID NOT CONNECT PROPERLY TO THE TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053799 ↗
• MalfunctionJan 2, 2026Device-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT THE BALL-BEARINGS ON THE UNIPOLAR/BIPOLAR ANGLED HANDLE WAS WORN. TROUBLE ATTACHING HEAD TRIALS ON TO HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23949572 ↗
• MalfunctionJan 2, 2026Device-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT THE BALL-BEARINGS ON THE UNIPOLAR/BIPOLAR ANGLED HANDLE WAS WORN. TROUBLE ATTACHING HEAD TRIALS ON TO HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23949398 ↗
• MalfunctionDec 22, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT STERILE PROCESSING DEPARTMENT COULD NOT CLEAN THESE INSTRUMENTS DUE TO DESIGN OF BALL BEARING. THE FAILURE WAS NOT DISCOVERED DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872608 ↗
• MalfunctionDec 22, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT STERILE PROCESSING DEPARTMENT COULD NOT CLEAN THESE INSTRUMENTS DUE TO DESIGN OF BALL BEARING. THE FAILURE WAS NOT DISCOVERED DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872592 ↗