Synthes (USA) Products LLC is recalling 242 units of its Low Profile Locking Screws used in femoral and tibial nailing surgical systems. The recall was issued because 42mm screws were mistakenly packaged in 46mm labels, and vice-versa. While the length etched directly on the metal screw is correct, the external packaging label is incorrect, which could lead to a surgeon selecting the wrong size during a procedure.
Using a screw of the wrong length during bone surgery can lead to improper fixation, screw protrusion, or tissue irritation. This may cause patient pain, post-operative complications, or the need for additional revision surgery to replace the incorrect hardware.
Used in RFN-ADVANCED Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
Used in RFN-ADVANCED Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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