Changeflow GovPing Pharma & Drug Safety FH Ortho Biolox Delta Femoral Head Recall - ANS...
Urgent Enforcement Amended Final

FH Ortho Biolox Delta Femoral Head Recall - ANSM Safety Alert R2610624

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Summary

ANSM has recorded a lot withdrawal action by FH Ortho affecting Biolox Delta femoral heads used in hip prostheses. The safety action is registered as No. R2610624. Healthcare establishments that received the recall letter should contact FH Ortho directly with any questions.

What changed

FH Ortho has initiated a lot withdrawal for Biolox Delta femoral heads used in hip prostheses, recorded by ANSM as safety action R2610624. The recall was communicated to affected healthcare establishments via a letter dated 16/04/2026.\n\nHealthcare facilities that received Biolox Delta femoral heads from the affected lots should review the attached FH Ortho correspondence and contact the manufacturer directly for受影响批次 details and next steps. No specific product lot numbers or quantities are stated in this alert summary.

What to do next

  1. Contact FH Ortho directly for further information

Archived snapshot

Apr 16, 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° R2610624 destiné aux établissements de santé L'ANSM a été informée de la mise en œuvre d’une action de retrait de lot effectuée par la société FH Ortho.
Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2610624.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société FH Ortho (16/04/2026)

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Last updated

Classification

Agency
ANSM
Filed
April 16th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
R2610624

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device recall response Market withdrawal
Geographic scope
France FR

Taxonomy

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

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