ARTICUL/EZE 2531-55-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295129226), received between Jun 13, 2019 and Mar 29, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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.

• MalfunctionMar 29, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  THIS PC IS TO CAPTURE THE 10 DEVICES RECEIVED IN (B)(4) AS VISUAL ANALYSIS EXHIBITED A REMARKABLE WORN CONDITION AND SEVERAL SCRATCHES THROUGHOUT THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16636560 ↗
• MalfunctionMar 29, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  THIS PC IS TO CAPTURE THE 10 DEVICES RECEIVED IN (B)(4) AS VISUAL ANALYSIS EXHIBITED A REMARKABLE WORN CONDITION AND SEVERAL SCRATCHES THROUGHOUT THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16636547 ↗
• MalfunctionFeb 8, 2023Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

  IT WAS REPORTED THAT THE TRIAL HEADS ARE WORN TO THE POINT THE PLASTIC IS FLAKING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16329345 ↗
• MalfunctionFeb 8, 2023Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

  IT WAS REPORTED THAT THE TRIAL HEADS ARE WORN TO THE POINT THE PLASTIC IS FLAKING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326057 ↗
• MalfunctionMay 26, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENTS ARE TOO WORN FOR SURGERY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891429 ↗
• MalfunctionMay 6, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WORN INSTRUMENTS IDENTIFIED BY SPD AS NEEDING TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783808 ↗
• MalfunctionNov 26, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE HEADS ARE ALL SCRATCHED - 3 SET OF 36 MM HEAD TRIALS - ALL NEED REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9378538 ↗
• MalfunctionNov 26, 2019Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE HEADS ARE ALL SCRATCHED - 3 SET OF 36 MM HEAD TRIALS - ALL NEED REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9378534 ↗
• MalfunctionNov 26, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE HEADS ARE ALL SCRATCHED - 3 SET OF 36 MM HEAD TRIALS - ALL NEED REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9378530 ↗
• MalfunctionJun 13, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE HEAD TRIAL IS SUPER LOOSE ON IMPLANT. DR WAS AFRAID IT WAS GOING TO FALL OFF DURING REDUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696017 ↗