SELF CENTERING 2055-14-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295084495), received between May 22, 2018 and Jul 23, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Crack” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT THE HANDLE BROKE ON BACK TABLE. NO DELAY, NO ADVERSE PATIENT EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19811294 ↗
• MalfunctionJan 4, 2024Crack; Crack

  IT WAS REPORTED THAT THE HANDLE HAS A CRACK IN THE PLASTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18442812 ↗
• MalfunctionMay 24, 2023Crack; Crack

  IT WAS REPORTED THAT THERE WERE TWO CRACKS NOTICED ON THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16995159 ↗
• MalfunctionMay 10, 2022Crack; Crack

  IT WAS REPORTED THAT THE MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED COMPLAINED ITEM AS HAVING A LONG CRACK DOWN THE HANDLE. THE INSTRUMENT WAS DEEMED TO BE NO LONGER FUNCTIONAL AND WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14346666 ↗
• MalfunctionNov 19, 2021Crack; Crack

  TRIAL REMOVAL HANDLE FOUND CRACKED AFTER DECONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12845420 ↗
• MalfunctionJan 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INSTRUMENT WAS REPORTED FOR UNKNOWN REASON. PRODUCT WAS RECEIVED AND THEN INVESTIGATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11181142 ↗
• MalfunctionApr 27, 2020Crack; Crack

  WHILE DOING ENDO HIP PROSTHESIS,SURGEON NOTICED 2 CRACKS ON THE PLASTIC HANDLE OF RING REMOVER. NO DAMAGE TO PATIENT, NO PARTS CAME OFF OF INSTRUMENT,NO SURGERY DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10002183 ↗
• MalfunctionJan 9, 2020Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FOUR UNIPOLAR TRIALS FROM THE MODULAR ENDO HEAD TRIAL INSTRUMENT SET DO NOT FIT INSIDE OF THE TRIAL HEADS IN THE CORRECT POSITION. THE WHITE HANDLE EXTRACTOR WILL NOT EXTRACT THE UNIPOLAR TRIALS FROM THE TRIAL HEAD. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9573196 ↗
• MalfunctionJul 23, 2018Break; Break

  IT WAS REPORTED THAT THE HANDLE OF ADAPTER REMOVER HAS BROKEN IN TWO. "THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7709929 ↗
• MalfunctionMay 22, 2018Bent; Bent

  IT WAS REPORTED THAT AN ADAPTER REMOVER INSTRUMENT WAS BENT AND DOES NOT CATCH. DISCOVERED UPON INSPECTION. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7533732 ↗