Nanoplasty 3D Bunion Correction System Implant recall
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Why was Nanoplasty 3D Bunion Correction System Implant 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: (01)00810111222464(17)290424(10)300542404
- Product
- Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
- Recalling firm
- Treace Medical Concepts, Inc.
- Quantity
- 40 kits containing 40 plates
- Distribution
- US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
- Recall date
- September 4, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)