Synthes recalls TFN-Advanced Femoral Nails with incorrect length labeling that could lead to improper surgical fixation. Affected units were sold with labels indicating 170mm but measuring 200mm or vice versa.
TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
Synthes is recalling certain femoral nails that may have incorrect length labels. This could cause improper surgical fixation if used in procedures requiring precise measurements.
The nails may be labeled as one length but measure another. This could lead to improper surgical fixation if the incorrect length is used during procedures requiring precise measurements.
Surgical patients who received these specific femoral nails during procedures. Orthopedic surgeons and hospitals using the recalled product are most at risk.
Check for the part number 04.037.212S and lot number 611P035 on the product packaging. The product is labeled as 170mm but may measure 200mm, or labeled as 200mm but may measure 170mm.
Look for the part number 04.037.212S and lot number 611P035 on the product packaging.
The recall is happening because the femoral nails may have incorrect length labels, which could lead to improper surgical fixation if used in procedures requiring precise measurements.
Check for the part number 04.037.212S and lot number 611P035 on the product packaging. The product is labeled as 170mm but may measure 200mm, or labeled as 200mm but may measure 170mm.
The recall record does not specify a remedy, so no action is required beyond checking the product label.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-1247-2023 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-1247-2023 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.