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BfArM publishes Link urgent field safety notice for Endo-Model Knee Fusion Nail, Femoral

🇩🇪 BfArM field safety notices · Wed 28 Oct 2026

The German regulator has posted a manufacturer safety notice for a femoral knee fusion nail, but the defect, affected lots and required actions appear only in an attached PDF.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 28 October 2026 from Waldemar Link GmbH & Co. KG. It concerns the Endo-Model Knee Fusion Nail, Femoral.

BfArM lists the device under the product group "Non-active implants - bone surgery" and files the notice under reference 50257/26. Its web entry does not describe the problem, the affected devices or the steps users should take.

Instead, the regulator directs readers to the manufacturer's Advisory Notice, attached as a 4MB PDF. BfArM flags that the file does not meet accessibility standards. Details on the nature of the issue, any lot or serial number scope, and corrective actions are therefore only in that document.

As general context, a field safety notice is the communication a manufacturer sends to customers and users when it takes a field safety corrective action for a medical device. Regulators such as BfArM often publish these notices on their websites.

What it means for your team

  • Quality and vigilance teams at hospitals and distributors should download and read the full Advisory Notice to establish whether affected Endo-Model Knee Fusion Nail, Femoral devices are in stock or have been implanted.
  • The BfArM page gives no defect, lot or action details, so internal decisions should rest on the manufacturer's notice and not on the regulator's summary.
  • Teams should reference BfArM number 50257/26 when logging the notice and tracking any response.

Official source: BfArM field safety notices ↗

Article written by VigiEye from the official source (BfArM field safety notices). AI-assisted; check the source before acting.

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