Evolution Mp Femoral Component Cs/Cr Porous Size 5 Right… recallZ-0699-2025 · MicroPort Orthopedics Inc. · initiated Oct 29, 2024
Class II Open, Classified All recalls posted in December 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MicroPort Orthopedics Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling Change Control
What the company is doing
On 10/29/24 field safety notices were emailed to customers who were asked to do the following: 1) Check inventory and quarantine all subject product(s) 2) Return affected products 3) Complete and return the acknowledgement form via email to [email protected] For questions or additional information please contact the firm at: +31 20 545 01 00, or [email protected]
Recall details
- Recall number
- Z-0699-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Oct 29, 2024
- Posted by the FDA
- Dec 18, 2024
- Recalling firm
- MicroPort Orthopedics Inc.
- Quantity
- 32
- Product code
- MBH
- FDA submissions
- K102380, K140735, K093552
- Distribution
- OUS: CN, GR, ES, ZA, FR, JP, IT
Product 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
Code information (models, lots, serial numbers)
REF/UDI-DI/Lot/Expiration: EFSRP5PR/M684EFSRP5PR1/2007116/2032-05-06. EFSRN6PL/M684EFSRN6PL1/MP2002559/2032-05-06.
Other devices under the same FDA submission
4 devices cleared under K102380, K140735, K093552 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- EVOLUTION EFSRP6PLMicroport Orthopedics Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- EVOLUTION EFSRP5PLMicroport Orthopedics Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- EVOLUTION EFSRP5PRMicroport Orthopedics Inc. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- EVOLUTION EFSRP6PRMicroport Orthopedics Inc. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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