MicroPort Orthopedics Inc. Recall 95672
Description: 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
MicroPort Orthopedics Inc. Recall 95672 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0699-2025 |
| Event ID | 95672 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | OUS: CN, GR, ES, ZA, FR, JP, IT |
| Quantity | 32 |
| Recall 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. |
| Device Classification | 20241225 |
| Device Code Info | REF/UDI-DI/Lot/Expiration: EFSRP5PR/M684EFSRP5PR1/2007116/2032-05-06. EFSRN6PL/M684EFSRN6PL1/MP2002559/2032-05-06. |
| Center Classification Date | 20241218 |
| Recall Initiation Date | 20241029 |
| Recalling Firm | MicroPort Orthopedics Inc. |
| Initial Notification | Letter |
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