Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Recall
- Recall Number
- Z-2718-2024
- Event Number
- 94977
- Firm
- Treace Medical Concepts, Inc.
- FEI Number
- 3011623994
- Product Code
- HRS
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- June 2, 2024
- Posted
- August 23, 2024
- Address
- 100 Palmetto Park Pl, Ponte Vedra, FL, 32081-6202
Description
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
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.
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.
US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
40 kits containing 40 plates