FDAFDA · Food and drugs·Recall number Z-2244-2024
EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
Published July 10, 2024 · Recall initiated: May 3, 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
One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- MicroPort Orthopedics Inc.
- Distributor
- International distribution in the country of China. There is no field inventory in the United States for either lot.
- Lot
- UDI: Part EFSRN3PL: Primary DI Number M684EFSRN3PL1, Part EFSRN4PR: Primary DI Number M684EFSRN4PR1; lot Number's: MP1982097, MP1982170; Catalog Number(s): EFSRN3PL, EFSRN4PR
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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