Class II

Medical Device Recall: Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.

Treace Medical Concepts, Inc. · June 2, 2024

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.

Distribution

US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.

States Affected

NATIONWIDE

Quantity Affected

40 kits containing 40 plates

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2718-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.