NA 8011-20-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024432987), received between Jul 1, 2024 and Jul 1, 2024 — classified as 1 malfunction.

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

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THERE WAS DEBRIS IN THE STERILE PACKAGE. THE PRODUCT WAS NOT USED PER THE SURGEON¿S DISCRETION. THE PRODUCT IS AVAILABLE FOR RETURN; HOWEVER, THE ¿HAIRS¿ HAVE BEEN DISCARDED. NO KNOWN IMPACT R CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652082 ↗

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