Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Recalled by Materialise N.V. Due to Images belonging to a different patient were used...
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 TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.
Quantity: 1 unit
Why Was This Recalled?
Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.
Where Was This Sold?
Worldwide Distribution to the Netherlands only.
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