Recall archive / FDA device enforcement
EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only. — FDA record Z-2244-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 3, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- MicroPort Orthopedics Inc.
- Quantity
- 40 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2244-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: Part EFSRN3PL: Primary DI Number M684EFSRN3PL1, Part EFSRN4PR: Primary DI Number M684EFSRN4PR1; lot Number's: MP1982097, MP1982170; Catalog Number(s): EFSRN3PL, EFSRN4PR |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the country of China. There is no field inventory in the United States for either lot.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 10, 2024
- Recall initiation date
- May 3, 2024
- Center classification date
- Jul 1, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.