Recall Z-2718-2024— Treace Medical Concepts, Inc.
Class II · Ongoing
Class II FDA medical device recall by Treace Medical Concepts, Inc., initiated 2024-06-02. It names one FDA 510(k) clearance: K240173. Product: Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.. 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..
- Recalling firm
- Treace Medical Concepts, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-02
- Firm location
- Ponte Vedra, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.