Heraeus Palamix Surgical Cement Safety Notice
Summary
ANSM has been informed of a safety action conducted by Heraeus regarding Palamix Uno and Palamix Duo orthopedic surgical cement mixing systems. The safety action is registered with ANSM under reference number R2609019. Affected users received direct correspondence from Heraeus, dated 23 April 2026, with the full text of the safety communication available as an attached document on the ANSM portal.
“L'ANSM a été informée de la mise en œuvre d'une action de sécurité effectuée par la société Heraeus.”
About this source
ANSM is France's national medicines and medical devices safety agency. Its safety information page publishes drug recalls, medical device field safety notices, batch withdrawals, and benefit-risk reassessments for products on the French market. Around 100 alerts a month, written in French. Many of the affected products are also sold across the EU and UK, so an ANSM recall often previews a wider regulatory response from the EMA, MHRA, BfArM, or AIFA in the days that follow. Watch this if you manufacture or distribute medical devices in Europe, run a hospital pharmacy network, or track post-market safety signals across the European market. Recent recalls include Monnal T60 ventilators, Murex HBsAg reagents, and Arrow Teleflex hemodialysis catheters.
What changed
ANSM has registered a safety action conducted by Heraeus regarding Palamix Uno and Palamix Duo orthopedic surgical cement mixing systems. The action, registered under reference R2609019, was communicated directly to affected users via a letter from Heraeus dated 23 April 2026. The ANSM notice serves as an official record of the manufacturer's safety intervention rather than an independent regulatory order.\n\nHealthcare facilities and professionals using Palamix Uno or Palamix Duo cement mixing systems should consult the attached manufacturer letter to determine the specific nature and implications of the safety action. Questions should be directed to Heraeus as the issuer of the safety communication, citing reference R2609019.
Archived snapshot
Apr 23, 2026GovPing 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.
Information n° R2609019 destinée aux pharmacies d'usage intérieur L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Heraeus.
Les utilisateurs concernés ont reçu le courrier ci-joint.
Cette action de sécurité est enregistrée à l’ANSM sous le n° R2609019. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Heraeus (23/04/2026)
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