Quick Facts at a Glance
- Recall Date
- September 17, 2025
- Hazard Level
- HIGH
- Brand
- CPM Medical Consultants
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- CPM Medical Consultants
- Product type
- Foot Plating System Instructions for Use
- Model numbers
- B565OS200020L, B565OS200025L, B565OS200120L, B565OS200125, B565OS200125L, B565OS200135, B565OS200324, B565OS200325 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 17, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
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
About This Product
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.
Why This Is Dangerous
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.”
Industry Context
This recall is not presented as part of a broader industry pattern.
Real-World Impact
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.
Practical Guidance
How to identify if yours is affected
- Check IFU DC-0495 revision level on your Fuse ULTRA Foot Plating System documentation.
- Verify the UDI-DI B565OS200020L or listed model numbers against your records.
- Confirm whether your facility uses the older sterilization steps that are no longer required in the US.
Where to find product info
UDI-DI on device labeling and the IFU; recall page at FDA enforcement notice; updated DC-0495 Rev D IFU
What timeline to expect
Updates available immediately; facilities should implement the updated IFU as soon as received; specific refund/replacement terms are not indicated
If the manufacturer is unresponsive
- Document all requests and responses with CPM; escalate to hospital compliance or legal if needed; consult FDA recall page for guidance.
- Maintain a copy of the original and updated IFU for regulatory records.
How to prevent similar issues
- Always verify sterilization requirements against the latest US guidelines.
- Request updated IFU and ensure staff are trained on the new steps.
- Maintain a robust record-keeping system for device documentation and recall updates.
Documentation advice
Record model numbers, UDI-DI, shipment dates, and store all recall communications.
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Product Details
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:
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 6 states affected (NV, TX, LA, WA, WI, FL)
- 21 affected model numbers/UDI-DI: B565OS200020L, B565OS200025L, B565OS200120L, B565OS200125, B565OS…
- Recall number Z-0230-2026
- Remedy: stop use and follow CPM instructions
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Safety Guide
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