Z-2718-2024Class II

Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st...

Name: Z-2718-2024 Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st...
Creator: Treace Medical Concepts, Inc.
Published: 2024-06-02
License: https://open.fda.gov/license/

Treace Medical Concepts, Inc. / initiated 2024-06-02 / Open, Classified

FDA source

Treace Medical Concepts, Inc. began a recall of Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component on 2024-06-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2718-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-02
Posted: 2024-08-23
Recalling firm: Treace Medical Concepts, Inc.
Product: Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Product code: HRS Plate, Fixation, Bone
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 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 in commerce: 40 kits containing 40 plates
Distribution: US Nationwide distribution in the states of CO, FL, MD, MI, NC, SC, TX, VA.
Product codes and lots: UDI: (01)00810111222464(17)290424(10)300542404

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2718-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2718-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23

Product code HRS

K240173Class IITreace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. / cleared 2024-02-22

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)