ARTICUL/EZE 2530-85-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295128984), received between Jul 13, 2017 and Apr 26, 2023 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2023Break; Material Discolored; Break; Material Discolored

  IT WAS REPORTED THAT THE "ARCTIC"/EZE TRAIL HEADS WERE CHIPPED AND THE COLORS ARE FADED. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817528 ↗
• MalfunctionApr 26, 2023Break; Material Discolored; Break; Material Discolored

  IT WAS REPORTED THAT THE ARTIC/EZE TRAIL HEADS WERE CHIPPED AND THE COLORS ARE FADED. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817526 ↗
• MalfunctionApr 26, 2023Break; Material Discolored; Break; Material Discolored

  IT WAS REPORTED THAT THE ARTIC/EZE TRAIL HEADS WERE CHIPPED AND THE COLORS ARE FADED. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817420 ↗
• MalfunctionOct 12, 2022Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE HEADS ARE OLD AND SCRATCHED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15588216 ↗
• MalfunctionOct 12, 2022Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE HEADS ARE OLD AND SCRATCHED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15588185 ↗
• MalfunctionNov 2, 2021Defective Device; Defective Device

  TRIAL HEADS ARE NOT THE RIGHT 12/14 TAPER, ONE IS SMALLER AND ONE IS OVERSIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739001 ↗
• MalfunctionJun 14, 2021Scratched Material; Scratched Material

  SCUFFED. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11996169 ↗
• 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 11891413 ↗
• MalfunctionFeb 15, 2021Break; Break

  IT WAS REPORTED THAT SEVERAL ITEMS THAT THE CENTRAL STERILE DEPARTMENT AT MEMORIAL HAVE REQUESTED TO BE REPLACED. 2 FEMORAL IMPACTORS HAVE CRACKS ON EACH NOTCH, 28 HEAD BALL TRIAL HAS A PIECE CHIPPED OFF THE SKIRT, I HAVE 3 GRATER HANDLES THAT APPEAR TO THE PEG IN SHAFT MISSING ON 2, AND A WARPED SPRING ON 1. THE HEAD IMPACTOR HAS CHIPS ON EDGES. I AM RETURNING EACH ITEM SO THE DAMAGE CAN BE VIEWED. NOBODY WAS INJURED, I AM RETURNING ALL, THIS DID NOT DELAY SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11329915 ↗
• MalfunctionNov 9, 2020Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE HEADS ARE SCRATCHED REALLY BAD AND NEED REPLACING. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10810306 ↗
• MalfunctionSep 17, 2019Material Discolored; Scratched Material; Material Discolored; Scratched Material

  IT WAS REPORTED THAT THE AGE RELATED FADING, DEEP SCRATCHES FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9076015 ↗
• MalfunctionJul 13, 2017Crack; Cut In Material; Crack; Cut In Material

  IT WAS REPORTED THAT UPON POST SURGICAL EXAMINATION THE TRIAL BALLS WERE NOTICED TO HAVE DEEP CRACKS AND GOUGES.

  Patient problems: No Information

  MAUDE report 6709916 ↗