Z-2718-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2024
- Initiation Date
- June 2, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 kits containing 40 plates
Product Description
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
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.
Distribution Pattern
US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
Code Information
UDI: (01)00810111222464(17)290424(10)300542404