Class II — Treace Medical Concepts, Inc.
| Recalling firm | Treace Medical Concepts, Inc. |
|---|---|
| Registered facility | TREACE MEDICAL CONCEPTS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component. |
| Quantity | 40 kits containing 40 plates |
| Distribution | US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA. |
| Initiated | 2024-06-02 |
| Classified | 2024-08-23 |
| Recall number | Z-2718-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Treace Medical Concepts, Inc. (Z-2718-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94977/
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