ANSM Safety Alert for Manosplint Cushionfoam Medical Device

Detected March 13th, 2026

Summary

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the Manosplint Cushionfoam medical device, identified by safety action number R2606620. This alert concerns a safety action initiated by the manufacturer, Kinetec SAS.

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What changed

The ANSM has issued a safety alert (R2606620) concerning the Manosplint Cushionfoam medical device, a safety action implemented by the manufacturer Kinetec SAS. Users concerned by this action have been notified directly by the company, and a letter from Kinetec dated March 12, 2026, detailing the action is available.

Manufacturers and potentially distributors of this device should review the safety alert and the accompanying letter from Kinetec SAS to understand the specific nature of the safety action and any implications for their operations. While the alert is primarily informational, it highlights a potential issue requiring attention from the supply chain. No specific compliance deadline or penalty information is provided in this notice, but prompt internal review is advised.

What to do next

Review ANSM safety alert R2606620 regarding Manosplint Cushionfoam.
Consult the provided letter from Kinetec SAS dated 12/03/2026 for details on the safety action.

Source document (simplified)

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Information n° R2606620 destinée aux fabricants L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Kinetec SAS.
Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2606620.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Kinetec (12/03/2026)