Treace Medical Concepts, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2718-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 2, 2024

Date Posted: September 4, 2024

Recall Number: Z-2718-2024

Event ID: 94977

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.

Status: Ongoing

Product Quantity: 40 kits containing 40 plates

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated