Synthes recalls TFN-Advanced Femoral Nails with incorrect length labels that could lead to improper surgical fixation. Affected units were sold between 2020-2022.
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. The recall affects medical devices sold to hospitals and surgeons.
The nails labeled as 200mm may actually be 170mm long, and those labeled as 170mm may be 200mm long. This size discrepancy could lead to improper surgical fixation if used in procedures.
Hospitals and surgeons who use Synthes TFN-Advanced Femoral Nails for hip fracture procedures are most at risk. The recall applies to specific model numbers sold between 2020 and 2022.
Check for the model number 04.037.213S on the nail packaging. The lot number 607P512 was used for affected units sold between 2020 and 2022.
Look for the model number 04.037.213S and lot number 607P512 on the nail packaging.
The recall is due to potential length discrepancies between the labeled and actual size of the femoral nails, which could affect surgical procedures.
Check the product label for the model number 04.037.213S and lot number 607P512. If you have these identifiers, contact Synthes for further instructions.
The recall indicates a potential for improper surgical fixation, but the official notice does not specify a risk of serious injury.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-1246-2023 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-1246-2023 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.
