FDA Device recall Z-2718-2024
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57
- FDA Device
- Class II
- ongoing
- Published 2024-09-04
On 2024-09-04 the FDA classified a Class II recall of Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57 by Treace Medical Concepts, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2718-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-02 |
| Published | 2024-09-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Treace Medical Concepts |
| Distribution | US |
Product
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Reason
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.
Identifiers
| code_info | UDI: (01)00810111222464(17)290424(10)300542404 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2718-2024%22
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