SELF CENTERING 2055-41-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295084587), received between May 7, 2022 and May 26, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE IMPACTED PRODUCTS HAD AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN IN SURGERY. DURING VISUAL EXAMINATION IT WAS DETERMINED THE DEVICES WERE WORN. (B)(4) AND (B)(4) ARE RELATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25276215 ↗
• MalfunctionSep 8, 2025Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material

  IT WAS REPORTED THAT CUTS INTO TRIAL ARE TOO DEEP FOR SPD TO ACCEPT. BRINGS ISSUE THAT THEY CANNOT FULLY STERILIZE INTO DEEP CUTS AND BACTERIA CAN STILL LIVE IN THERE. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22998671 ↗
• MalfunctionOct 14, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT HEAD TRIALS DID NOT FIT ON TRIAL STICK AND SIZES ARE NOT VISIBLE. THESE WERE FOUND AFTER THE CASE SO THERE WERE NO ADVERSE CONSEQUENCES AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441125 ↗
• MalfunctionOct 14, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT THE HEAD TRIALS DID NOT FIT ONTO TRIAL STICK. THE SIZES ARE NOT VISIBLE ON THE HEAD TRIALS. THESE WERE FOUND AFTER THE CASE SO THERE WERE NO ADVERSE CONSEQUENCES AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439086 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PRODUCTS WERE WORN, AND THE SIZES WERE NOT VISIBLE. THE LOT NUMBERS WERE NOT VISIBLE ON THE HEAD TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302153 ↗
• MalfunctionMay 15, 2024Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT STERILIZATION COULD NOT GET THE TWO PIECES APART. THERE WAS NO DELAY AND NO ADVERSE EVENT REPORTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326093 ↗
• MalfunctionSep 20, 2023Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT THE INSTRUMENTS HAVE BECOME DAMAGED. THE WRITING FOR THE TRIAL SIZE HAS RUBBED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17779901 ↗
• MalfunctionNov 9, 2022Crack; Crack

  IT WAS REPORTED THAT THE BIPOLAR TRIAL CRACKED WHEN TRYING TO REMOVE IT FROM TRIAL HANDLE. SURGEON SAID CALCAR PLANER WAS OLD AND DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15760941 ↗
• MalfunctionSep 12, 2022Break; Break

  IT WAS REPORTED THAT THE TRIAL HEAD HAD PLASTIC RIPPING OFF AS IT WAS REMOVED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401362 ↗
• MalfunctionMay 7, 2022Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT THE SIZING INFORMATION WORN OFF TRIALS DUE TO MULTIPLE AUTOCLAVING/USAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316849 ↗