Synthes USA recalled 122 locking intramedullary nail screws used in RFN-Advanced and Tibial Nail Advanced systems. The recall covers worldwide distribution including the US and Canada. The packaging labeling misstates screw length while the etched length on the screw is correct. Healthcare providers should stop using the device immediately and follow recall instructions from Synthes.
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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These locking screws are used with intramedullary nail systems to secure implants in long bones. They are supplied in various lengths and require precise labeling to guide surgical use.
Packaging length labeling errors may lead to incorrect screw length selection during surgery, potentially compromising fixation.
This recall is not described as part of a broader industry pattern.
The mislabeling could require additional surgeries or revisions if incorrect screws are implanted due to length confusion.
Official recall notices and the FDA enforcement page linked in the recall notice.
Remediation timelines vary; expect several weeks for replacements or refunds as directed by Synthes.
Keep the recall notice, packaging images, lot numbers, and all correspondence with the manufacturer and procurement.
Product Code: 04.045.342TS. GTIN: 10886982301390. Lot Number: 31756P9. Expiration Date: 08/31/2025. System: RFN-Advanced Retrograde Femoral Nailing (RFNA) System and Tibial Nail Advanced System. Quantity: 122 units. Distribution: Worldwide, including US states 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.
No injuries or incidents have been reported.
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