Fuse ULTRA Foot Plating System models OS200400-OS422630 have outdated sterilization instructions that no longer apply in the US. No action needed as the instructions are being updated.
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.
Fuse recalls certain foot plating systems for updated instructions. The old sterilization requirements (3 minutes at 134-137°C) no longer apply in the US, so no action is needed.
The recall addresses outdated sterilization instructions that previously required 3 minutes at 134-137°C (273-279°F) and 5-10 minutes drying time. These requirements do not apply in the United States, so the instructions were updated to remove them.
Users of Fuse ULTRA Foot Plating System models OS200400 through OS422630 with IFU DC-0495 versions before Rev D are affected. Medical professionals using these devices for foot plating procedures are most at risk.
Check your Fuse ULTRA Foot Plating System model number (OS200400-OS422630) and IFU DC-0495 version. The recall covers all versions before Rev D, with lots up to September 2025.
Verify your device model number and IFU version to confirm if it's affected.
No action is needed. The instructions are being updated to remove outdated sterilization requirements that no longer apply in the US.
Models OS200400 through OS422630 with IFU DC-0495 versions before Rev D, and lots up to September 2025.
The recall updates instructions to remove sterilization requirements that no longer apply in the United States.
We’ve drafted a message you can send Fuse to request your refund or repair — edit it as you like.
Subject: Recall Z-0230-2026 — Fuse Fuse Hello, I own a Fuse that is covered by recall Z-0230-2026 from Fuse. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
