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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Exocad GmbH: exoplan 3.1 Rijeka Dental Software Recalled for Incorrect Drill Protocol Display

Agency Publication Date: September 25, 2023
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Summary

Exocad GmbH has recalled 96 licenses of its exoplan version 3.1 Rijeka dental software due to a filtering error in the Step-by-Step Full Drill Protocol export functionality. This software defect causes the system to display unsupported sleeve height positions for surgical guides instead of filtering them out based on the specific drill protocol selected. This software is used by dental professionals to plan implant placements within a patient's anatomy, and the error could lead to the production of inaccurate surgical guides.

Risk

If an unsupported or improper sleeve height position is used in a surgical guide, it may lead to incorrect dental implant placement during surgery, which can result in patient injury or poor surgical outcomes.

What You Should Do

  1. Identify if you are using exoplan version 3.1 Rijeka software by checking your license and software version information within the application.
  2. Check your software for the specific affected UDI-DI identifiers: (01)4260521365026(10)A03B01E8439 (US), (01)4260521365026(10)A03B01E8588 (SR1 US), or (01)4260521365026(10)A03B01E8606 (SR1 US offline).
  3. Dental professionals should immediately contact Exocad GmbH to confirm the steps for receiving a software patch or update to resolve the library filtering error.
  4. Consult with your healthcare organization's IT department or the manufacturer regarding any surgical guides produced using the 'Step-by-Step Full Drill Protocol' export functionality while this version was in use.
  5. Contact Exocad GmbH directly at their headquarters in Darmstadt, Germany, via the contact information provided in your initial e-mail notification or through their official website for technical support.
  6. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

manufacturer or healthcare provider Consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: exoplan version 3.1 Rijeka Software
Model / REF:
UDI-DI: (01)4260521365026(10)A03B01E8439 (US)
(01)4260521365026(10)A03B01E8588 (SR1 US)
(01)4260521365026(10)A03B01E8606 (SR1 US offline)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92921
Status: Active
Manufacturer: Exocad GmbH
Manufactured In: Germany
Units Affected: 96 licenses
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.