Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS20012

FDA device recall Z-0230-2026 · posted 2025-10-21 · Open, Classified

Recall details

Recalling firm: CPM Medical Consultants, LLC.
Reason for recall: Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for 5-10 minutes drying time, because these requirements do not apply in the United States.
Action taken: On 9/17/2025, correction notices were mailed to customers and distributors who were informed of the following: - The only sterilization requirement now shown on the new Rev D IFU is 4 mins exposure time at 132-Degrees C (270-Degrees F) and 20-30mins drying time. - All affected versions of the IFU should be immediately discarded. - You can access the e-IFU at: https://fusemedical.com/wp-content/uploads/2025/09/Fuse-ULTRA-Foot-Plating-System-IFU-Rev-D-9.2025.pdf - Please pass on this Medical Device Correction to all users of the products and all other people who need to be aware within your organization. - If you have or may have distributed the products listed, please identify and promptly notify those recipients with a copy of this notice, response form, and updated IFU. - Complete and return the response form via email to FMohammad@FuseMedical.com If you have any questions, contact the firm at info@fusemedical.com
Root cause: Labeling design
Status: Open, Classified
Product code: HRS
Quantity affected: 3317
Distribution: US Nationwide distribution in the states of NV, TX, LA, WA, WI, FL.
Date initiated: 2025-09-17
Date posted: 2025-10-21
Location: Farmers Branch, TX

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