Device product

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

Z-2718-2024

June 02, 2024

Class II

Product summary

Firm: Treace Medical Concepts, Inc.
Event: Event 94977
Status: Ongoing
Classification: Class II
Quantity: 40 kits containing 40 plates
Official record key: device-enforcement:Z-2718-2024

Official wording

Reason: 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.

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.