CPM Medical Consultants recalls 3,317 Fuse ULTRA Foot Plating System Instructions for Use issued nationwide in the United States. The recall addresses sterilization steps that are no longer required in the United States. Healthcare providers should stop using the current IFU and follow CPM’s recall instructions.
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 Fuse ULTRA Foot Plating System is used in orthopedic procedures to stabilize foot fractures via plating techniques. Health care facilities rely on precise IFU guidelines for sterilization and handling.
The recall removes a sterilization step that previously existed in some versions of the IFU. The change applies to US procedures, potentially affecting how devices are processed.”
This recall is not presented as part of a broader industry pattern.
Facilities must update practices to align with US-only sterilization requirements. The recall affects 3,317 units and requires immediate action to prevent procedural confusion and ensure compliance.
UDI-DI on device labeling and the IFU; recall page at FDA enforcement notice; updated DC-0495 Rev D IFU
Updates available immediately; facilities should implement the updated IFU as soon as received; specific refund/replacement terms are not indicated
Record model numbers, UDI-DI, shipment dates, and store all recall communications.
Product: Fuse ULTRA Foot Plating System Instructions for Use Models/UDI-DI: B565OS200020L; B565OS200025L; B565OS200120L; B565OS200125; B565OS200125L; B565OS200135; B565OS200324; B565OS200325; B565OS200326; B565OS200400; B565OS200401; B565OS200516; B565OS200518; B565OS200520; B565OS200522; B565OS200616; B565OS200618; B565OS200620; B565OS200622; B565OS216150 Quantity recalled: 3317 units Distribution: United States — nationwide in NV, TX, LA, WA, WI, FL Sold by: To medical facilities and healthcare providers (no consumer retail data provided) Price: Not specified Recall date: 2025-09-17; Report:
No injuries or incidents have been reported.
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