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 Patient-specific surgical guide and instrument Recalled by Materialise USA LLC Due to A patient specific case of Signature Personalized Patient...
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 USA LLC directly.
Affected Products
Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
Quantity: 1
Why Was This Recalled?
A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.
Where Was This Sold?
One consignee, Indiana.
About Materialise USA LLC
Materialise USA LLC has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report