Quality & complianceOfficial

BfArM publishes field safety notice for Coltene Tenax Fiber Trans dental post over labelling problem

🇩🇪 BfArM field safety notices · Wed 21 Oct 2026

Germany's regulator lists an urgent notice for Coltene/Whaledent's translucent esthetic post system, flagging a labelling problem and the absence of EU market permission.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 21 October 2026 for the TENAX FIBER TRANS Translucent Esthetic Post System, made by Coltene/Whaledent, Inc. The entry is filed under reference 45231/26 and the product group dental products, specifically dental prostheses.

BfArM's listing describes the issue as a labelling problem and adds that the product has no EU market permission. The wording suggests the device is not authorised for placing on the EU market, although the entry does not explain how the labelling issue relates to that status.

The notice itself is available as a 170 KB PDF on the BfArM site. The listing as provided does not set out which lots or serial numbers are affected, how many units are involved, or what corrective actions the manufacturer is asking users and distributors to take. It also does not name any incidents or injuries.

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

What it means for your team

  • Quality and regulatory teams in the German and wider EU supply chain should check whether TENAX FIBER TRANS posts are held in stock or distributed, and review the full PDF notice for specific instructions.
  • The 'no EU market permission' statement makes this a market-access and compliance concern as well as a labelling one, particularly for importers and distributors.
  • Lot scope and required actions are not stated in the listing, so teams should not assume any particular remedy until they have read the notice itself.

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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