Treace Medical Concepts, Inc. recalls Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate a…

Recall date

June 2, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2718-2024

FDA classification

Class II

Brand / firm

Treace Medical Concepts, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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