CPM Medical Consultants, LLC. is recalling 3,317 Instruction for Use manuals for the Fuse ULTRA Foot Plating System. The instructions are being updated because they previously included a sterilization option (3 minutes at 134-137 degrees Celsius) that is not applicable for use in the United States. Healthcare facilities must ensure they are using the correct, United States-approved sterilization methods to avoid potential patient safety risks.
Following incorrect sterilization instructions could lead to surgical instruments that are not properly disinfected. This increases the risk of serious complications, including surgical site infections, for patients undergoing foot plating procedures.
All versions of IFU DC-0495 prior to Rev D.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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