NA 8011-20-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024433021), received between Jul 20, 2026 and Jul 21, 2026 — classified as 2 deaths.

1 other recall cover devices cleared under the same FDA submission (K001733); 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.

• DeathJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE SURGERY AND SUBSEQUENTLY PASSED AWAY IN THE FOLLOWING DAYS OF THE PROCEDURE, ON AN UNKNOWN DATE, DUE TO UNKNOWN MEDICAL COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25888960 ↗
• DeathJul 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE SURGERY AND SUBSEQUENTLY PASSED AWAY IN THE FOLLOWING DAYS OF THE PROCEDURE, ON AN UNKNOWN DATE, DUE TO UNKNOWN MEDICAL COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25873197 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001733. One submission often covers many models, so check the product and lot details in each record.

• Z-1699-2009 · Jun 8, 2009 · Terminated
  Zimmer Allen medullary cement plugs, 1 - 20 dia. flange/10 mm dia. core, 1 - 24 mm dia. flange/12 mm dia. core (polyethylene with barium sulfate) with inserter, sterile, Zimmer, Wa