Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 ...
FDA Recall #Z-2718-2024 — Class II — June 2, 2024
Product Description
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Reason for Recall
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.
Recalling Firm
Treace Medical Concepts, Inc. — Ponte Vedra, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
40 kits containing 40 plates
Distribution
US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
Code Information
UDI: (01)00810111222464(17)290424(10)300542404
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated