Treace Medical Concepts, Inc.: Nanoplasty 3D Bunion Correction System Recalled for Potential Screw Stripping

Agency Publication Date: August 23, 2024

Summary

Treace Medical Concepts, Inc. is recalling 40 Nanoplasty 3D Bunion Correction System Implant kits, specifically the 1st Metatarsal Plate component, due to a manufacturing issue. The locking screws and inserter rods may not fit correctly, causing the screws to strip or fail to seat fully into the plates during surgery. This can lead to complications during the bunion correction procedure or potential issues with the implant's stability.

Risk

The mechanical interference between the screws and plates may cause the screws to strip or remain loose. This can result in surgical delays, improper fixation of the bone, or the need for additional medical intervention to correct the implant placement.

What You Should Do

Identify if you have the affected Nanoplasty 3D Bunion Correction System Implant (Model Number: SK57) by checking the surgical kit for the 1st Metatarsal Plate (Component Number: 01-00066).
Verify the Unique Device Identifier (UDI) on the product packaging: (01)00810111222464(17)290424(10)300542404.
If you are a healthcare provider or facility in possession of these kits, immediately stop using them and quarantine the affected inventory.
Contact Treace Medical Concepts, Inc. at their headquarters in Ponte Vedra, Florida, to arrange for the return of the affected kits and to receive further instructions regarding replacements.
Patients who have recently undergone bunion surgery using this system should contact their orthopedic surgeon or healthcare provider if they experience unusual pain, swelling, or concerns regarding their recovery.
For additional information, contact the FDA medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and coordination

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Nanoplasty 3D Bunion Correction System Implant

Model / REF:

SK57

01-00066

Lot Numbers:

300542404

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94977

Status: Active

Manufacturer: Treace Medical Concepts, Inc.

Sold By: Specialized medical distributors; Direct to hospitals/surgical centers

Manufactured In: United States

Units Affected: 40 kits containing 40 plates

Distributed To: Colorado, Florida, Maryland, Michigan, North Carolina, South Carolina, Texas, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected Nanoplasty 3D Bunion Correction System Implant (Model Number: SK57) by checking the surgical kit for the 1st Metatarsal Plate (Component Number: 01-00066).

Verify the Unique Device Identifier (UDI) on the product packaging: (01)00810111222464(17)290424(10)300542404.

If you are a healthcare provider or facility in possession of these kits, immediately stop using them and quarantine the affected inventory.

Contact Treace Medical Concepts, Inc. at their headquarters in Ponte Vedra, Florida, to arrange for the return of the affected kits and to receive further instructions regarding replacements.

Patients who have recently undergone bunion surgery using this system should contact their orthopedic surgeon or healthcare provider if they experience unusual pain, swelling, or concerns regarding their recovery.

For additional information, contact the FDA medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.