Farmers Branch, TX, United States
CPM Medical Consultants, LLC. recalls
1 recall recorded since 2018, most recently on 17 September 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 17 September 2025
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of NV, TX, LA, WA, WI, FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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, O
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.