Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as
Summary
The FDA issued a Class II for Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System conta by Treace Medical Concepts, Inc.. Reason: Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping an.
Details
Source
Device Recall
External ID
Z-2718-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
Product Description
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Lot/Code Info: UDI: (01)00810111222464(17)290424(10)300542404
Quantity Affected: 40 kits containing 40 plates
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-02
Company
Ponte Vedra, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 409 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Treace Medical Concepts, Inc. has 7 FDA actions in our database, including 1 recall and 6 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Treace Medical Concepts, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Treace Medical Concepts, Inc. have FDA actions?
Treace Medical Concepts, Inc. has 7 FDA actions in our database, including 1 recall and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2718-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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