Recall archive / FDA device enforcement
EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base — FDA record Z-0276-2023
Reported terminated
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 Oct 28, 2022. 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 Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
- Reason
- One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.
- Classification
- Class II
- Recalling firm
- MicroPort Orthopedics Inc.
- Quantity
- 22 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0276-2023
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/DI 0 0192629 08293 9, Lot 1916715 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Feb 22, 2023
- Recall initiation date
- Oct 28, 2022
- Center classification date
- Nov 22, 2022
- Termination date
- Sep 10, 2026
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.