Changeflow GovPing Healthcare & Life Sciences Adhese 2 Dental Amalgam Recall, Ivoclar Vivaden...
Urgent Enforcement Removed Final

Adhese 2 Dental Amalgam Recall, Ivoclar Vivadent AG

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Summary

ANSM issued safety alert R2609516 regarding a batch recall of Adhese 2 dental amalgam by Ivoclar Vivadent AG. Healthcare facilities, dental centers, and dental surgeons using this product should verify their inventory for affected lots. The company has directly notified impacted users with return instructions.

Published by ANSM on ansm.sante.fr . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

ANSM (French National Agency for Medicines and Health Products Safety) has recorded a batch withdrawal (recall) of Adhese 2 dental amalgam manufactured by Ivoclar Vivadent AG under safety action reference R2609516. The company initiated the recall and has issued direct notification to affected users with instructions.

Dental practices, health centers, and hospitals should immediately check their inventory for Adhese 2 dental amalgam from affected lots and follow the return procedures provided in the company letter. Users with questions should contact Ivoclar Vivadent AG directly. The recall is currently in progress and regulated entities should act promptly to prevent continued use of the affected product.

What to do next

  1. Check inventory for Adhese 2 dental amalgam from the affected lot(s)
  2. Follow return instructions provided by Ivoclar Vivadent AG
  3. Contact Ivoclar Vivadent AG directly for questions regarding the recalled product

Archived snapshot

Apr 3, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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Rappel n° R2609516 destiné aux établissements de santé, centres de santé et chirurgiens dentistes L'ANSM a été informée de la mise en œuvre d’un retrait de lot effectué par la société Ivoclar Vivadent AG.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2609516. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Ivoclar Vivadent AG (03/04/2026)

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Last updated

Classification

Agency
ANSM
Filed
April 3rd, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
R2609516

Who this affects

Applies to
Healthcare providers Manufacturers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical Device Distribution Medical Device Use
Threshold
Specific lot(s) of Adhese 2 dental amalgam manufactured by Ivoclar Vivadent AG
Geographic scope
France FR

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Product Safety Medical Devices

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