Nanoplasty 3D Bunion Correction System Implant — Class II medical device recall Z-2718-2024
Ongoing recall by Treace Medical Concepts, Inc., reported 2024-09-04, distributed nationwide. Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than antic
| Recall number | Z-2718-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Treace Medical Concepts, Inc., Ponte Vedra, FL, United States |
| Recall initiated | 2024-06-02 |
| Classified | 2024-08-23 |
| Reported by FDA | 2024-09-04 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00810111222464 |
| Model numbers | SK57 |
Product
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2718-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.