Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Signature Patient-Specific Surgical Guides Recalled by Materialise N.V. Due to Potential inaccuracies in the alignment of the guides....
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
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
Quantity: 4
Why Was This Recalled?
Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
Where Was This Sold?
This product was distributed to 3 states: ID, MI, TX
About Materialise N.V.
Materialise N.V. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report