FDAFDA · Food and drugs·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.
Published September 4, 2024 · Recall initiated: June 2, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Treace Medical Concepts, Inc.
- Distributor
- US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
- Lot
- UDI: (01)00810111222464(17)290424(10)300542404
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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