NA 32-8105-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024274082), received between Aug 12, 2021 and Oct 11, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K040389); 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 16, 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.

• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER FURTHER REVIEW, IT WAS DETERMINED TO BE NOT REPORTABLE AS REVIEW OF THE STERILE CERTS INDICATES THE DEVICES WERE STERILIZED PER VALIDATED PROCESS / REQUIREMENTS.

  Patient problems: Bacterial Infection; Unspecified Infection; Wound Dehiscence

  MAUDE report 17913682 ↗
• MalfunctionAug 12, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12312814 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040389. One submission often covers many models, so check the product and lot details in each record.

• Z-1700-2009 · Jun 8, 2009 · Terminated
  Zimmer Coonrad/Morrey total elbow cement restrictor with nozzle, 1 - 16 mm, 1 - 25 mm, sterile, Zimmer, Dover, Ohio; Catatog Number: 32810503800. Total joint arthroplasy to contro