Changeflow GovPing Drug Safety Spinal Plug Safety Alert for Pharmacies
Priority review Notice Removed Final

Spinal Plug Safety Alert for Pharmacies

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Detected March 13th, 2026
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Summary

The French ANSM has been informed of a lot recall action for spinal plugs (Airplug T10-T12) by Groupe Lépine, registered under action number R2607057. Pharmacies are directed to consult the provided letter from the manufacturer for details.

What changed

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding a lot recall of spinal plugs (specifically, the Centro-medullary cement obturator, Diaphyseal obturator Airplug T10-T12) manufactured by Groupe Lépine. This action, registered under number R2607057, affects pharmacies and is detailed in a letter from the manufacturer dated March 12, 2026.

Pharmacies are advised to consult the manufacturer's letter for specific instructions and to direct any questions to Groupe Lépine. This notice serves as an alert to ensure awareness and proper handling of the affected product, implying a need for inventory checks and potential removal of specific lots from circulation to ensure patient safety.

What to do next

  1. Review the manufacturer's letter regarding the spinal plug lot recall.
  2. Identify and segregate affected spinal plug lots as per manufacturer instructions.
  3. Direct any product-specific inquiries to Groupe Lépine.

Source document (simplified)

A+ A-

Information n° R2607057 destinée aux pharmacies d'usage intérieur L'ANSM a été informée de la mise en œuvre d’une action de retrait de lot effectuée par la société Groupe Lépine.
Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607057.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Groupe Lépine (12/03/2026)

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
Various
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Healthcare providers
Geographic scope
INT

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Topics
Product Safety Medical Devices

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