Treace Medical Concepts, Inc.: Device Recall
Recall #Z-2718-2024 · 06/02/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2718-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Treace Medical Concepts, Inc.
- Status
- Ongoing
- Date Initiated
- 06/02/2024
- Location
- Ponte Vedra, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 kits containing 40 plates
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.
Product Description
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Distribution Pattern
US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.