Foot plating systems recalled to remove a sterilization option from instructions
CPM Medical Consultants is updating the Fuse ULTRA Foot Plating System instructions for use to remove a sterilization option that does not apply in the United States.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a documentation update: the record describes removing an inapplicable sterilization option from the instructions, with no device defect or reported harm.
Plain-English summary
The Fuse ULTRA Foot Plating System Instructions for Use are being updated across a range of models including OS200400, OS200401, OS328017, OS200020L and OS200025L.
The instructions are being updated to remove the second option of sterilization requirements, which was 3 minutes exposure time at 134-137 degrees C and 40 mBar for 5-10 minutes drying time, because those requirements do not apply in the United States.
The action covers 3,317 units, all versions of IFU DC-0495 prior to Revision D and all lots up to 10 September 2025. The product was distributed in Nevada, Texas, Louisiana, Washington, Wisconsin and Florida. The FDA has classified the action as Class II.
The enforcement record describes an instructions update rather than a device defect, and reports no injuries. Facilities should use the updated instructions when sterilizing the system.
The recalled product
- Product
- 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…
- Manufacturer
- CPM Medical Consultants, LLC.
- Affected units
- 3,317
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- B565OS200025L
- B565OS200120L
- B565OS200125
- B565OS200125L
- B565OS200135
- B565OS200324
- B565OS200325
- B565OS200326
- B565OS200400
- B565OS200401
- B565OS200516
- B565OS200518
- B565OS200520
- B565OS200522
- B565OS200616
- B565OS200618
- B565OS200620
- B565OS200622
- B565OS216150
- B565OS218150
Distribution
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