SELF CENTERING 2055-54-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295084716), received between Sep 4, 2018 and May 21, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Break; Scratched Material

  IT WAS REPORTED THAT THE TRIALS WERE GOUGED/SCRATCHED AND ¿CP¿ WOULD NOT STERILIZE THEM ANYMORE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243273 ↗
• MalfunctionMay 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE BIPOLAR HEAD TRIAL WOULD NOT COME OFF THE ANGLED INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230823 ↗
• MalfunctionJan 30, 2025Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE DEVICE WORN OFF BIPOLAR TRIALS FOR SIZE NUMBERS, NO SURGERY WAS DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273226 ↗
• MalfunctionNov 4, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE INSTRUMENT HAS BEEN REPORTED FOR AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY. UPON MANUFACTURERS INVESTIGATION IT WAS NOTED THAT THE INSTRUMENT WAS SCRATCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599764 ↗
• 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 20441793 ↗
• MalfunctionOct 14, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT THE HEAD TRIALS DO 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 20439289 ↗
• MalfunctionSep 27, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE MOD ENDO HEAD TRIALS ARE OLD AND DON'T FIT ON THE TRIAL STICK. THESE WERE FOUND AFTER A CASE SO THERE WAS NO SURGICAL DELAY AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20328399 ↗
• MalfunctionAug 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THERE WAS SIGNIFICANT WEAR ON MOD-ENDO TRIAL HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19908296 ↗
• MalfunctionJan 3, 2024Device-Device Incompatibility; Scratched Material; Illegible Information; Device-Device Incompatibility; Scratched Material; Illegible Information

  IT WAS REPORTED THAT THE TRIALS ARE ALL DAMAGED AND UNABLE TO READ THE SIZES. THEY ALSO HAVE DEEP SCRATCHES AND CUTS IN THEM DUE TO NOT LOCKING IN THE HANDLES CORRECTLY. THEY HAVE BEEN DAMAGED DUE TO NOT BEING ABLE TO GET THEM OFF THE HANDLES WITHOUT USING SURGICAL INSTRUMENTS TO GET THEM OFF. DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18435260 ↗
• MalfunctionNov 6, 2023Device-Device Incompatibility; Scratched Material; Illegible Information; Device-Device Incompatibility; Scratched Material; Illegible Information

  IT WAS REPORTED THAT THE TRIALS ARE ARE ALL DAMAGED AND UNABLE TO READ THE SIZES. THEY ALSO HAVE DEEP SCRATCHES AND CUTS IN THEM DUE TO NOT LOCKING IN THE HANDLES CORRECTLY. THEY HAVE BEEN DAMAGED DUE TO NOT BEING ABLE TO GET THEM OFF THE HANDLES WITHOUT USING SURGICAL INSTRUMENTS TO GET THEM OFF. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18081129 ↗
• MalfunctionSep 26, 2023Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  INSTRUMENTS HAVE BECOME DAMAGED WRITING FOR THE TRIAL SIZE HAS RUBBED OFF. ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON 9/15/2023 STATED: B. PLEASE PROVIDE THE LOT NO. OF THE REPORTED DEVICES. -LOT NUMBERS CANNOT BE READ AS THEY HAVE WORN OFF OF THE DEVICES, THERE IS 3 OF EACH INSTRUMENT. C. PLEASE CONFIRM THE DATE OF EVENT, IT HAS BEEN ADDED AS PER THE SOURCE FILE. -(B)(6) 2023. D. WHAT IS THE ALERT DATE OF THE COMPLAINT? WHEN WERE YOU MADE AWARE OF THE EVENT? - (B)(6) 2023. E. PLEASE CLARIFY WHAT DOES IT MEAN WITH "INSTRUMENTS HAVE BECOME DAMAGED " THE WRITING ON THE SIDE OF THE TRIALS, WHICH THE SURGEONS NEEDS TO READ TO BE ABLE TO DECIDE WHICH FINAL IMPLANT TO USE IS NO LONGER READABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818331 ↗
• MalfunctionJul 14, 2023Break; Contamination /Decontamination Problem; Scratched Material; Break; Contamination /Decontamination Problem; Scratched Material

  IT WAS REPORTED THAT THE PLASTIC WAS CHIPPED OR SCRATCHED.

  Patient problems: Insufficient Information

  MAUDE report 17326825 ↗
• 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 14317029 ↗
• MalfunctionSep 27, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE ITEMS WERE WORN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533960 ↗
• MalfunctionJul 22, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE INSTRUMENTS ARE DAMAGED AND NEEDS REPLACEMENT. THIS WAS ONLY NOTICED DURING SURGERY, NO HARM OR DELAY TO THE PATIENT OR THEATRE LIST/ PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12210445 ↗
• MalfunctionMar 29, 2021Scratched Material; Scratched Material

  MODULAR HEAD BALLS HAVE DAMAGE, (GOUGES, CHIPS AND SCRAPES) MAKING IT DIFFICULT FOR STERILE PROCESSING TO CLEAN NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581055 ↗
• MalfunctionAug 12, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE MODULAR ENDO HEAD TRIALS ABSOLUTELY WILL NOT ATTACH TO THE TRIAL HANDLE WHICH LEAD TO SURGEON FRUSTRATION. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8885036 ↗
• MalfunctionSep 4, 2018Naturally Worn; Naturally Worn

  MDR STAFF HAS INDICATED THAT PRODUCT IS WORN AND DAMAGED. PRODUCT IS NO LONGER FUNCTIONAL AND REPLACEMENT IS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENT DIRECTLY TO CUSTOMER AT THE FOLLOWING: (B)(6). N/C PO WILL BE PROVIDED WHEN AVAILABLE. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7841560 ↗