Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Recalled by Materialise N.V. Due to The wrong tibia guide was included intended for...

Date: April 26, 2023
Company: Materialise N.V.
Status: Completed
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Materialise N.V. directly.

Affected Products

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

Quantity: 2 Guides

Why Was This Recalled?

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

Where Was This Sold?

International Distribution to countries of: Germany, Netherlands

About Materialise N.V.

Materialise N.V. has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report