Materialise N.V. recalls MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched de…

Recall date

April 26, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2213-2023

FDA classification

Class II

Brand / firm

Materialise N.V.

Sold / distributed

International Distribution to countries of: Germany, Netherlands

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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. Ref: KNM-ZB02-00-01