FDA Enforcement
Class II
Ongoing
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Recall: Z-2718-2024
·
Reported September 4, 2024
Enforcement
- Recall Number
- Z-2718-2024
- Event ID
- 94977
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Treace Medical Concepts, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- September 4, 2024
- Initiation Date
- June 2, 2024
- Classification Date
- August 23, 2024
- Address
- 100 Palmetto Park Pl, Ponte Vedra, FL, 32081-6202, United States
Description
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
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 Info
UDI: (01)00810111222464(17)290424(10)300542404
Distribution
US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
Quantity
40 kits containing 40 plates