Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE Recalled by Materialise USA LLC Due to Shipped femur guide contained a non-conformance which could...
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
REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.
Quantity: 1
Why Was This Recalled?
Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
Where Was This Sold?
This product was distributed to 1 state: MO
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