CPM Medical Consultants recalled 3,317 units of its foot plating system on September 17, 2025. The recall addresses updated sterilization instructions that incorrectly included requirements not applicable in the U.S. Patients and healthcare providers must stop using the device immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact CPM Medical Consultants, LLC. or your healthcare provider for instructions
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The recalled models include OS200400, OS200401, OS328017, and many others. The devices were distributed nationwide in states such as Nevada, Texas, Louisiana, Washington, Wisconsin, and Florida.
The recall involves an update to the instructions for use regarding sterilization. The prior instructions included a sterilization method not required for devices sold in the United States.
No specific injury or incident reports have been mentioned in relation to this recall. The recall is precautionary based on incorrect sterilization instructions.
Stop using the foot plating system immediately. Follow the recall instructions provided by the manufacturer and contact CPM Medical Consultants or your healthcare provider for further guidance.
For more information, contact CPM Medical Consultants at [Insert Phone Number]. Visit their website for recall instructions and updates.
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