Home / Recalls / Medical Devices
Treace Medical Concepts, Inc. recalls Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as
Recalled September 4, 2024 · FDA recall Z-2718-2024 · Treace Medical Concepts
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. · FDA Class II
Units
40 kits containing 40 plates
Sold at
US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
Description
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.
Product
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Manufacturer(s)
Treace Medical Concepts, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →