The Recall Desk
HighFDA (Devices)·Z-2718-2024·Announced 2024-09-04

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.

What this means for you

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.
Category
Medical Device — Orthopedic Implant
Hazard
  • screw-stripping
  • improper-seating
  • device-malfunction

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

Distributed nationwide across the United States.

Related recalls

Same category