NA 32-8106-00-12 (REF 32-8106-000-12)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024639799), received between Jun 29, 2022 and Jun 20, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K181307, K973357); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO BUSHING WEAR ON THE IMPLANT CAUSING METAL-ON-METAL EROSION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17165178 ↗
• InjuryJun 29, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL SURGERY OVER 30 YEARS AGO. THE PATIENT UNDERWENT A REVISION AND PLACEMENT OF A SPACER MOLD DUE TO INFECTION AND DISLOCATION. THEY PUT IN A NEW IMPLANT BUT WASN'T SURE IF THEY HEARD THE CLICK. A WEEK LATER THE PATIENT HAD DISLOCATED AGAIN, AND THE PATIENT UNDERWENT A SECOND REVISION. THE PIN APPEARED TO HAVE DISENGAGED, POSSIBLY LEADING TO THE DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 14851230 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181307, K973357. One submission often covers many models, so check the product and lot details in each record.

• Z-0537-2013 · Nov 19, 2012 · Terminated
  COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET STERILE PROD CLASS: 4100 OPERATION:9000 QTY/P