Device product
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
Z-0699-2025
Product summary
- Event
- Event 95672
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32
- Official record key
device-enforcement:Z-0699-2025
Official wording
Reason: 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.
Code information: REF/UDI-DI/Lot/Expiration: EFSRP5PR/M684EFSRP5PR1/2007116/2032-05-06. EFSRN6PL/M684EFSRN6PL1/MP2002559/2032-05-06.
Distribution pattern: OUS: CN, GR, ES, ZA, FR, JP, IT
Derived failure modes
-
Labeling or packaging
incorrect packaging