Nanoplasty Bunion Correction System (Treace Medical) – Screw Interference (2024)
Manufacturing issues can cause potential interference with screw seating and device function.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Brand
Treace Medical Concepts, Inc.
Lot Codes / Batch Numbers
UDI: (01)00810111222464(17)290424(10)300542404
Products Sold
UDI: (01)00810111222464(17)290424(10)300542404
Treace Medical Concepts, Inc. is recalling Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st due to Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping an. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026