Z-0699-2025Class II

EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL...

Name: Z-0699-2025 EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL...
Creator: MicroPort Orthopedics Inc.
Published: 2024-10-29
License: https://open.fda.gov/license/

Microport Orthopedics Inc. / initiated 2024-10-29 / Open, Classified / root cause: labeling and UDI

FDA source

MicroPort Orthopedics Inc. began a recall of 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... on 2024-10-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0699-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-29
Posted: 2024-12-18
Recalling firm: Microport Orthopedics Inc.
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
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
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.
Root cause tag: labeling and UDI
FDA 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 [email protected] For questions or additional information please contact the firm at: +31 20 545 01 00, or [email protected]
Quantity in commerce: 32
Distribution: OUS: CN, GR, ES, ZA, FR, JP, IT
Product codes and lots: REF/UDI-DI/Lot/Expiration: EFSRP5PR/M684EFSRP5PR1/2007116/2032-05-06. EFSRN6PL/M684EFSRN6PL1/MP2002559/2032-05-06.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0699-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0699-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-18

Product code MBH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)