FDAClass IIDecember 25, 2024

Evolution MP Femoral Component Cs/cr Porous recall

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…

Why was Evolution MP Femoral Component Cs/cr Porous 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

REF/UDI-DI/Lot/Expiration: EFSRP5PR/M684EFSRP5PR1/2007116/2032-05-06. EFSRN6PL/M684EFSRN6PL1/MP2002559/2032-05-06.

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…
Recalling firm
MicroPort Orthopedics Inc.
Quantity
32
Distribution
OUS: CN, GR, ES, ZA, FR, JP, IT
Recall date
December 25, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls