FDA Medical Device Recalls (openFDA)
Treace Medical Concepts, Inc.: Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
- Recall number
- Z-2718-2024
- 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.
- Status
- Open, Classified
- Initiated
- 2024-06-02
- Posted
- 2024-08-23
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- UDI: (01)00810111222464(17)290424(10)300542404
- 510(k) numbers
- ["K240173"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3011623994
- Firm city
- Ponte Vedra
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28