Ponte Vedra, FL, United States
Treace Medical Concepts, Inc. recalls
1 recall recorded since 2018, most recently on 2 June 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 June 2024
- 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.
- Distribution
- US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2718-2024
- Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.