Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
FDA Recall Z-2718-2024 · Posted 2024-08-23
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Recalling FirmTreace Medical Concepts, Inc.
Recall StatusOpen, Classified
Product CodeHRS
Date Initiated2024-06-02
Product Quantity40 kits containing 40 plates
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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