Synthes (USA) Products LLC recalled 122 surgical screws on September 26, 2025. Mislabeling of screw lengths poses a serious risk to patients. Affected products include those used in the RFN-ADVANCED and Tibial Nail Advanced Systems.
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
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The recall involves LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER, Product Code: 04.045.342TS. The screws were distributed worldwide, including in the United States and Canada.
The screws are mislabeled, with 42mm screws packaged as 46mm and vice versa. This mislabeling can lead to incorrect surgical procedures.
No injuries or incidents have been reported to date. However, the potential for serious complications exists due to the incorrect labeling.
Stop using the screws immediately. Follow the recall instructions from Synthes or consult your healthcare provider.
For further instructions, contact Synthes (USA) Products LLC. Visit the FDA website for more details.
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