Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nanoplasty 3D Bunion Correction System Implant Recalled by Treace Medical Concepts, Inc. Due to Potential issue causing a higher frequency of interference...
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 Treace Medical Concepts, Inc. directly.
Affected Products
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Quantity: 40 kits containing 40 plates
Why Was This Recalled?
Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping and/or not fully seating in the plates and/or interface issues between inserter rods and plates.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Treace Medical Concepts, Inc.
Treace Medical Concepts, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report