Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0230-2026 — Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, OS200125L, OS200135, OS200324, OS200325, OS200326, OS328026, OS328028C, OS216150, OS218150, OS292110, OS292120, OS292160, OS292200, OS200516, OS200518, OS200520, O

U.S. FDA — Device Enforcement · United States · 2025-09-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0230-2026
Date of alert: 2025-09-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: CPM Medical Consultants, LLC.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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