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U.S. Department of Health and Human Services

Class 2 Device Recall Nanoplasty 3D Bunion Correction System Implant

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 Class 2 Device Recall Nanoplasty 3D Bunion Correction System Implantsee related information
Date Initiated by FirmJune 02, 2024
Date PostedAugust 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2718-2024
Recall Event ID 94977
510(K)NumberK240173 
Product Classification Plate, fixation, bone - Product Code HRS
ProductNanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Code Information UDI: (01)00810111222464(17)290424(10)300542404
FEI Number 3011623994
Recalling Firm/
Manufacturer		 Treace Medical Concepts, Inc.
100 Palmetto Park Pl
Ponte Vedra FL 32081-6202
For Additional Information ContactRachel Osbeck
904-373-5940
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionDistributors 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 in Commerce40 kits containing 40 plates
DistributionUS Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HRS
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