Zimmer Biomet Patient Specific Instruments KNM-ZB03-00-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05420060310034), received between Oct 28, 2021 and Oct 28, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K173445, K221337, K251554, K253793); 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.

• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISTAL FEMORAL RESECTIONS WERE BIGGER THAN PLANNED .THE SURGERY WAS PROLONGED FOR 100 MIN TO REDO BONE CUTS, PLAN REEVALUATION AND KNEE BALANCING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12711377 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173445, K221337, K251554, K253793. One submission often covers many models, so check the product and lot details in each record.

• Z-2213-2023 · Apr 26, 2023 · Completed
  MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patie