Synthes (USA) Products LLC recalled 120 low-profile locking screws for intramedullary nails used in the RFN-Advanced Retrograde Femoral Nailing System and the Tibial Nail Advanced System. The recall covers devices distributed worldwide through healthcare providers. The external packaging mislabels screw lengths: 42 mm screws are labeled 46 mm and 46 mm screws are labeled 42 mm. Hospitals and spine
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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This product is a low-profile locking screw used with intramedullary nail systems for orthopedic procedures, including retrograde femoral and tibial nailing. Surgeons rely on precise screw lengths for stable fixation.
The external packaging mislabels screw lengths, which could lead to selecting the incorrect screw length during surgery. The etched screw length on the device itself is correct.
This recall is not described as part of a broader industry pattern.
The discrepancy could affect surgical planning and implant fit. The recall involves 120 units distributed worldwide. No injuries or incidents are reported in the available data.
Look for Product Code 04.045.346TS, GTIN 10886982301413, Lot 31756P7, Expiration 08/31/2025 on the packaging.
Recall timeline and replacement process are not specified. Follow instructions from Synthes and the healthcare facility.
Keep the recall notice, photos of affected packaging, Product Code, GTIN, Lot Number, and all correspondence with the manufacturer.
Model numbers and identifiers: Product Code 04.045.346TS. GTIN 10886982301413. Lot Number 31756P7. Expiration Date 08/31/2025. Quantity recalled: 120 units. Distribution: Worldwide with US distribution in AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and Canada. Sold through healthcare providers. Manufacturer: Synthes (USA) Products LLC.
No injuries or incidents have been reported.
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