Reported Jul 26, 2023 · Completed

MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched…

Materialise N.V.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Materialise N.V. · Technologielaan 15 · Heverlee, N/A · N/A

Is this the product you have?

  • 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 patient-specific pre-operative plan to the OR
  • RefKNM-ZB02-00-01
Lot codes and dates
  • UDI-DI(01)05420060310027
  • Lot Number/Case Number
    • ZB22UHINEF
    • ZB23MANOLA
Amount recalled
2 Guides

Why it was recalled

The wrong tibia guide was included intended for a different patient case.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.