Synthes (USA) Products LLC recalled 120 units of medical screws on September 26, 2025. The screws were incorrectly labeled, posing a risk to patients. The recall affects multiple states and Canada.
Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Synthes (USA) Products LLC or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
The recalled product is a low profile locking screw, model number 04.045.346TS, used in RFN-ADVANCEDTM Retrograde Femoral Nailing System and Tibial Nail Advanced System. The screws were distributed worldwide and sold in the U.S. states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX, and in Canada.
The etched length on the screw is correct, but the packaging is misleading. Screws labeled as 46mm were actually 42mm, and vice versa. This discrepancy could lead to improper surgical procedures.
There have been no reported injuries or incidents as a result of this recall. However, the potential for surgical errors remains high due to incorrect labeling.
Patients and healthcare providers should stop using the screws immediately. Contact Synthes (USA) Products LLC or your healthcare provider for further instructions on the recall.
For more information, contact Synthes (USA) Products LLC or visit their website. The recall can also be tracked at the FDA website.
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