Recall Z-2718-2024 ยท HRS Plate, Fixation, Bone
Treace Medical Concepts, Inc.
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
| Date | Aug 23, 2024 (initiated Jun 2, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 40 kits containing 40 plates |
| Distribution | US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K240173 | Treace Medical Systems (TMC) Plating System Treace Medical Concepts, Inc., Feb 22, 2024 |