Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Reported: September 4, 2024 Initiated: June 2, 2024 #Z-2718-2024
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.
Details
- Recalling Firm
- Treace Medical Concepts, Inc.
- Units Affected
- 40 kits containing 40 plates
- Distribution
- US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
- Location
- Ponte Vedra, FL
Frequently Asked Questions
What product was recalled? ▼
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.. Recalled by Treace Medical Concepts, Inc.. Units affected: 40 kits containing 40 plates.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 4, 2024. Severity: Moderate. Recall number: Z-2718-2024.
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