Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as
FDA device recall Z-2718-2024 · posted 2024-08-23 · Open, Classified
Recall details
- Recalling firm
- Treace Medical Concepts, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- HRS
- Quantity affected
- 40 kits containing 40 plates
- Distribution
- US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
- Date initiated
- 2024-06-02
- Date posted
- 2024-08-23
- Location
- Ponte Vedra, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Treace Medical Systems (TMC) Plating System (K240173) | Treace Medical Concepts, Inc. | 2024-02-22 |