Trabecular Metal® 00-4500-024-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024269606), received between Jan 8, 2021 and Jan 8, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K120906); 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.

• InjuryJan 8, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ANKLE PROCEDURE. SUBSEQUENTLY, THE PATIENT HAS REPORTED PAIN AND IMPINGEMENT ISSUES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 11139356 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120906. One submission often covers many models, so check the product and lot details in each record.

• Z-0306-2020 · Oct 10, 2019 · Terminated
  TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 00450002300 00450002400 0045000250
• Z-0476-2014 · Nov 12, 2013 · Terminated
  Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducin
• Z-0475-2014 · Nov 12, 2013 · Terminated
  Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing
• Z-0477-2014 · Nov 12, 2013 · Terminated
  Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reduci