Nanoplasty System recallZ-2718-2024 · Treace Medical Concepts, Inc. · initiated Jun 2, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Treace Medical Concepts, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Distributors were contacted via phone or in person to hold product starting on 06/02/2024. Recall notifications were disseminated on 06/13/2024 via email containing the recall letter, acknowledgement, and shipping label for return. On 07/29/2024, Treace Medical contacted surgeons via letter. Surgeons were instructed to monitor patients for adverse events and to complete and return the acknowledgement form.
Recall details
- Recall number
- Z-2718-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 2, 2024
- Posted by the FDA
- Aug 23, 2024
- Recalling firm
- Treace Medical Concepts, Inc.
- Quantity
- 40 kits containing 40 plates
- Product code
- HRS
- FDA submissions
- K240173
- Distribution
- US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
Product description
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Code information (models, lots, serial numbers)
UDI: (01)00810111222464(17)290424(10)300542404
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Nanoplasty System SK57Treace Medical Concepts, Inc. · Plate, Fixation, Bone1 recall18 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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