NA 32-8105-35-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024274044), received between Dec 17, 2019 and Jun 5, 2023 — classified as 4 injuries.

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

10 other recalls cover devices cleared under the same FDA submission (K001989, K181307); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A REVISION APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO BONE FRACTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 17065677 ↗
• InjuryMay 23, 2023Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 8 DAYS POST IMPLANTATION DUE TO AN INCORRECT IMPLANT POSITIONING DURING THE INITIAL PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 16987201 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Hyporesponsive to stimuli; Peripheral Nervous Injury

  MAUDE report 12737512 ↗
• InjuryDec 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ANTHROPLASTY SUBSEQUENTLY, THE PATIENT WAS REVISED TO DISASSOCIATION OF THE PIN SEEN ON X-RAY APPROXIMATELY FIVE (5) MONTHS POST IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Information

  MAUDE report 9481432 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001989, K181307. One submission often covers many models, so check the product and lot details in each record.

• Z-1000-2020 · Dec 12, 2019 · Terminated
  Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component;
• Z-0301-2020 · Oct 10, 2019 · Terminated
  Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 32810503000 32810600012 32810600013 32855510796 32855510797 32855510799 32855510800 32855510801
• Z-1239-2018 · Jan 24, 2018 · Terminated
  Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
• Z-2752-2016 · Aug 16, 2016 · Terminated
  Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process
• Z-0538-2013 · Nov 19, 2012 · Terminated
  Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar and humeral components are connec
• Z-1054-2009 · Jan 30, 2009 · Terminated
  Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 6 inch length, sterile, Zimmer Inc, Warsaw, IN; REF 32-8105-027-06. The device is utilized for a
• Z-1058-2009 · Jan 30, 2009 · Terminated
  Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, long, sterile, Zimmer, Warsaw, IN; REF 32-8105-093-02. The device is utilize
• Z-1057-2009 · Jan 30, 2009 · Terminated
  Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, left, long, sterile, Zimmer, Warsaw, IN; REF 32-8105-093-01. The device is utilized
• Z-1053-2009 · Jan 30, 2009 · Terminated
  Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch length, sterile, Zimmer Inc., Warsaw, IN; REF 32-8105-027-04. The device is utilized for a
• Z-0767-04 · Mar 16, 2004 · Terminated
  Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. no. 32-