Nanoplasty 3D Bunion Implant System Recalled for Mechanical Failure Risk
Treace Medical Concepts is recalling its Nanoplasty 3D Bunion Implant (Model SK57) nationwide due to potential mechanical failures where locking screws may strip or fail to seat properly. No injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with potential mechanical failure modes (screw stripping, improper seating) that could compromise implant function or require revision surgery. No injuries or illnesses reported. Meets rubric criterion for High severity as a risk-of-harm surgical device without reported adverse events.
Plain-English summary
The Nanoplasty 3D Bunion Correction System Implant, Model SK57, is a surgical implant used for bunion correction, manufactured by Treace Medical Concepts, Inc. The recall affects approximately 40 kits containing 40 implant plates distributed nationwide in Colorado, Florida, Maryland, Michigan, North Carolina, South Carolina, Texas, and Virginia.
The recall was initiated due to a potential manufacturing issue causing a higher-than-expected frequency of interference between locking screws and inserter rods. This interference can result in locking screws stripping or failing to fully seat in the implant plates, or improper interface connections between inserter rods and plates.
No injuries or illnesses related to this issue have been reported to date. Patients with questions should discuss their implant status with their surgeon. Healthcare providers should discontinue use of affected implants and contact Treace Medical Concepts regarding replacement or return options.
The recalled product
- Product
- Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
- Manufacturer
- Treace Medical Concepts, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: (01)00810111222464(17)290424(10)300542404
Distribution
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