Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Recalled by Materialise USA LLC Due to The box of guides for a specific case...
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
Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
Quantity: 1
Why Was This Recalled?
The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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