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

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.

Details from the source

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. Quantity: 40 kits containing 40 plates Lot/code info: UDI: (01)00810111222464(17)290424(10)300542404

UPC codes

00810111222464

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.