Synthes recalls low-profile locking screws with incorrect length labeling on packaging. 42mm screws labeled as 46mm and vice versa. This could cause improper fitting in medical procedures. Affected units sold from 2023-08-31.
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 low-profile locking screws that have incorrect length labels on their packaging. This could lead to improper surgical fitting if used in medical procedures. The recall affects specific product codes sold up to August 31, 2025.
The packaging incorrectly labels the screw length: 42mm screws are labeled as 46mm and 46mm screws are labeled as 42mm. This mismatch could lead to improper surgical fitting if the wrong length is used during procedures.
Medical professionals using Synthes' RFN-ADVANCEDTM Retrograde Femoral Nailing system or Tibial Nail Advanced System are most at risk. The affected product code is 04.045.342TS.
Check for product code 04.045.342TS on the packaging. The screws are part of Synthes' RFN-ADVANCEDTM system and were sold up to August 31, 2025.
Look for the product code 04.045.342TS on the packaging to confirm if it's affected.
The packaging incorrectly labels the screw length: 42mm screws are labeled as 46mm and 46mm screws are labeled as 42mm.
Check the product code on the packaging. If it's 04.045.342TS, contact Synthes for guidance.
The recall is for labeling errors, not a safety hazard. The risk is low as it only affects proper fitting during medical procedures.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0229-2026 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0229-2026 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.
