Drug recall
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st…
FDA recall event 94977 · Class II · Treace Medical Concepts, Inc.
Key facts
| Event ID | 94977 |
|---|---|
| Recall numbers | Z-2718-2024 |
| Recalling firm | Treace Medical Concepts, Inc. |
| Product type | Devices |
| Products | Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jun 2, 2024 |
| Report date | Sep 4, 2024 |
| City | Ponte Vedra |
| State | FL |
| Country | United States |
| FEI number | 3011623994 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: