FDA-Device2024-09-04Class II
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Treace Medical Concepts, Inc.
Hazard
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.
Sold states
US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
Affected count
40 kits containing 40 plates
Manufactured in
100 Palmetto Park Pl, Ponte Vedra, FL, United States
Products
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2718-2024Don't want to check this manually?
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