Recall Z-0699-2025 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
MicroPort Orthopedics Inc.
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
| Date | Dec 18, 2024 (initiated Oct 29, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling Change Control |
| Action | 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 |
| Quantity | 32 |
| Distribution | OUS: CN, GR, ES, ZA, FR, JP, IT |
| FDA record | Open on fda.gov |