ARTICUL/EZE 2530-69-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295128892), received between Dec 11, 2017 and Apr 2, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionApr 2, 2026Material Deformation; Scratched Material

  IT WAS REPORTED THAT THE HEAD OF THE INSTRUMENT IS SCRATCHED AND DENTED AND IS NOT BROKEN IN HALF. IT DID NOT CAUSE A DELAY, AND NOTHING WAS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766594 ↗
• MalfunctionSep 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 22+4 HEAD TRIAL AND 45/22 BIMENTUM HEAD TRIAL CONSTRUCT DISSOCIATED MULTIPLE TIMES DURING TRIAL REDUCTION. THIS EXTENDED THE TIME OF SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192160 ↗
• MalfunctionJan 4, 2024Break; Break

  TRIAL GUIDE HOLE DAMAGED. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18446266 ↗
• MalfunctionOct 2, 2023Break; Crack; Break; Crack

  THE TRIAL HEAD IS CRACKED AND NEEDS REPLACEMENT. THERE WAS NO PATIENT HARM AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851314 ↗
• MalfunctionMay 1, 2023Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT GOT CAUGHT UNDER A RACK AND BROKE. ALL PIECES WERE COLLECTED. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843297 ↗
• MalfunctionMay 26, 2022Crack; Illegible Information; Crack; Illegible Information

  IT WAS REPORTED THAT THE TRIAL HEAD WAS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14514858 ↗
• MalfunctionMay 13, 2020Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  DURING THE COVID PERIOD, HOSPITAL STAFF AT (B)(6) IN (B)(6) EXAMINED A VARIETY OF SETS AND CAME ACROSS SEVERAL DAMAGED INSTRUMENTS (7 TOTAL) IN THEIR PINNACLE BANTAM SET THAT REQUIRE REPLACING: THE PINNACLE IMPACTOR ADAPTER AND SHELL TRIAL WERE CROSS THREADED AND NO LONGER USABLE ((B)(4)). THE 28MM LINER IMPACTOR WAS GAUGED (B)(4)). THE ARTICULEZE TRIAL BALLS AND NEUTRAL TRIAL LINERS WERE ALSO GAUGED AND NOT USABLE DUE TO WEAR AND TEAR ((B)(4)). ALL ITEMS WERE DISCARDED. NO PATIENT OR INTRA-OP ISSUES AS THIS DID NOT OCCUR IN THE OPERATING ROOM. PLEASE SEND REPLACEMENTS TO THE FOLLOWING ADDRESS: (B)(6). N/C PO TO FOLLOW. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.: TRUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10053542 ↗
• MalfunctionDec 11, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE HEAD TRIAL BROKE TRAILING. NO SURGICAL DELAY. ALL PIECES RETRIEVED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7103752 ↗