Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
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.
US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2718-2024