EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NO
FDA device recall Z-0699-2025 · posted 2024-12-18 · Open, Classified
Recall details
- Recalling firm
- MicroPort Orthopedics Inc.
- Reason for recall
- 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.
- Action taken
- 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 PostMarket@ortho.microport.com For questions or additional information please contact the firm at: +31 20 545 01 00, or PostMarket@ortho.microport.com
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- MBH
- Quantity affected
- 32
- Distribution
- OUS: CN, GR, ES, ZA, FR, JP, IT
- Date initiated
- 2024-10-29
- Date posted
- 2024-12-18
- Location
- Arlington, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS (K140735) | Microport Orthopedics, Inc. | 2014-08-29 |
| EVOLUTION MP TOTAL KNEE SYSTEM (K102380) | Wrightmedicaltechnologyinc | 2011-01-07 |
| EVOLUTION MP TOTAL KNEE SYSTEM (K093552) | Wrightmedicaltechnologyinc | 2010-03-04 |