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

This recall is currently active, issued August 23, 2024. It was issued by Treace Medical Concepts, Inc..

Company

Treace Medical Concepts, Inc.

Recall Initiated

June 2, 2024

Posted

August 23, 2024

Recall Number

Z-2718-2024

Quantity

40 kits containing 40 plates

Firm Location

Ponte Vedra, FL

Official Source

View on FDA website ↗

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.

Lot / Code Info

UDI: (01)00810111222464(17)290424(10)300542404

Root Cause

Under Investigation by firm

Action Taken

Distributors were contacted via phone or in person to hold product starting on 06/02/2024. Recall notifications were disseminated on 06/13/2024 via email containing the recall letter, acknowledgement, and shipping label for return. On 07/29/2024, Treace Medical contacted surgeons via letter. Surgeons were instructed to monitor patients for adverse events and to complete and return the acknowledgement form.