FDAFDA · Food and drugs·Recall number Z-0699-2025
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component
Published December 25, 2024 · Recall initiated: October 29, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MicroPort Orthopedics Inc.
- Distributor
- OUS: CN, GR, ES, ZA, FR, JP, IT
- Lot
- REF/UDI-DI/Lot/Expiration: EFSRP5PR/M684EFSRP5PR1/2007116/2032-05-06. EFSRN6PL/M684EFSRN6PL1/MP2002559/2032-05-06.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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