Synthes recalls LOW PROF LCKNG SCREW (Product Code 04.045.346TS) due to incorrect length labeling on packaging. 42mm screws labeled as 46mm and vice versa. No immediate action needed as this is a labeling error, not a safety hazard.
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.
Synthes is recalling a specific type of surgical screw due to incorrect length labeling on the packaging. This means some screws labeled as 46mm are actually 42mm, and vice versa. This labeling error does not pose a safety risk but could lead to improper use in medical procedures.
The packaging incorrectly labels the screw length. Screws that should be 46mm are labeled as 42mm, and vice versa. This could lead to using the wrong screw size during surgery, potentially causing complications.
Surgical professionals using the RFN-ADVANCEDTM Retrograde Femoral Nailing system or Tibial Nail Advanced System with the specific product code 04.045.346TS are affected. Patients receiving these screws during surgery may be at risk if the incorrect screw size is used.
Check the product code on the packaging: 04.045.346TS. Look for the screw size labeled as 42mm or 46mm on the packaging. The screws are used in RFN-ADVANCEDTM systems and have an expiration date of August 31, 2025.
Check the product code on the packaging to confirm it is 04.045.346TS.
No, this is a labeling error that does not pose a safety risk. The screws are still safe to use as long as the correct size is selected.
Look for the product code 04.045.346TS on the packaging and check the screw size labeled as 42mm or 46mm.
No, the recall is for labeling accuracy, not safety. You can continue using the screws as long as you verify the correct size.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0228-2026 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0228-2026 from Synthes. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
