ARTICUL/EZE 2530-70-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295128908), received between May 13, 2020 and May 28, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2024Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT THE TRAIL HEAD WAS SCUFFED AND DIFFICULT TO INSERT INTO TRAIL.

  Patient problems: Insufficient Information

  MAUDE report 19404465 ↗
• MalfunctionApr 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON COULDN'T FIT 22 +7 OR 22+9 CORAIL HEAD TRIALS ON CORAIL NECK TRIALS. WE TRIED MULTIPLE VARIATIONS BUT NONE WOULD GO ON, THEY SEEMED TOO TIGHT FOR THE NECK TRIAL. SURGEON HAD TO TRIAL ON THE DEFINITIVE STEM IMPLANT. THERE WAS A TEN MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16760715 ↗
• MalfunctionNov 15, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE TRIALS WERE DAMAGED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15799243 ↗
• MalfunctionMay 13, 2020Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  DURING THE COVID PERIOD, HOSPITAL STAFF AT (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 (221750048 & 221701038). THE 28MM LINER IMPACTOR WAS GAUGED (221750006). THE ARTICULEZE TRIAL BALLS AND NEUTRAL TRIAL LINERS WERE ALSO GAUGED AND NOT USABLE DUE TO WEAR AND TEAR (253070000, 253069000, 221828044 & 221828046). ALL ITEMS WERE DISCARDED. NO PATIENT OR INTRA-OP ISSUES AS THIS DID NOT OCCUR IN THE OPERATING ROOM. (B)(6). 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); DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4); DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4); DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4); DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4) DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4); DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10053557 ↗