ELITE 2522-00-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295128298), received between Mar 26, 2019 and May 21, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT AN IMPACTOR AND AN INTRODUCER ARE BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 22062766 ↗
• MalfunctionApr 25, 2025Break; Break

  IT WAS REPORTED THAT STEM INTRODUCER WAS BROKEN. THERE WAS NO EFFECT DURING SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 21912905 ↗
• MalfunctionJan 21, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN INSTRUMENTS. THE PLASTIC CRACKED ON TWO T-HANDLES AND ONE C-STEM INSERTER WHICH HAVE TO BE DISCARDED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21198840 ↗
• MalfunctionJun 12, 2024Break; Scratched Material; Break; Scratched Material

  THE HANDLE OF THE CSTEM INTRODUCER HAS BEEN DAMAGED. A PIECE OF THE PLASTIC GRIP SCRATCHED DEEP AND IS NOT APPROPRIATE FOR STERILIZATION. NO PATIENT HARM, NO DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525429 ↗
• MalfunctionDec 29, 2022Break; Break

  INSTRUMENT BROKE DURING HIP SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067560 ↗
• MalfunctionFeb 28, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED AS DEFICIENT DUE TO FAIR WEAR AND TEAR. SURGERY NOT AFFECTED. OPERATION TIME NOT LENGTHENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13619745 ↗
• MalfunctionJan 11, 2022Break; Break

  INSTRUMENT HANDLE BROKE INTO TWO PIECES DURING IMPACTION. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13222761 ↗
• MalfunctionMar 26, 2019Component Missing; Component Missing

  DISCARDED INSTRUMENTS FROM A C STEM AMT CONSIGNMENT KIT DISCARDED MAKING THE KIT INCOMPLETE AND NOT USABLE. MISSING ITEMS: HOHMANN RETRACTOR 2181-10-000; PINNACLE ALIGNMENT ROD 9653-68-000; BOX CHISEL SMALL 2002-31-000; STEM INTRODUCER 2522-00-502; 36MM -2 TRIAL HEAD 2531-5-0000.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8451514 ↗