Reported Sep 4, 2024 · Ongoing
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate…
Treace Medical Concepts, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Treace Medical Concepts, Inc. · 100 Palmetto Park Pl · Ponte Vedra, FL · 32081-6202
Is this the product you have?
- Nanoplasty 3D Bunion Correction System Implant
- Model NumberSK57. System contains the 01-00066 1st Metatarsal Plate as a component
- Lot codes and dates
- UDI(01)00810111222464(17)290424(10)300542404
- Amount recalled
- 40 kits containing 40 plates
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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