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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Evolution MP Knee Implants Recalled for Incorrect Packaging and Labeling

Agency Publication Date: December 18, 2024
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Summary

MicroPort Orthopedics Inc. is recalling 32 units of Evolution MP Femoral Component knee implants. The recall affects the porous size 5 right primary (model EFSRP5PR) and non-porous size 6 left primary (model EFSRN6PL) components. While the implants themselves are correctly marked, the outer packaging may contain incorrect labeling, potentially leading to the selection of the wrong size or type during surgical procedures. No incidents or injuries have been reported to date.

Risk

Incorrect labeling on the packaging could cause a surgeon to select and attempt to use the wrong size or type of implant for a patient. If the error is not identified before or during surgery, it could result in improper fit, surgical delays, or the need for revision surgery.

What You Should Do

  1. The recalled products are MicroPort Evolution MP Femoral Components: Porous Size 5 Right Primary (model EFSRP5PR, lot 2007116, expiration 2032-05-06) and Non-Porous Size 6 Left Primary (model EFSRN6PL, lot MP2002559, expiration 2032-05-06).
  2. Stop using the recalled device. Contact MicroPort Orthopedics Inc. or your distributor to arrange return, replacement, or correction.
  3. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY
Variants: Porous, Size 5 Right Primary
Model / REF:
EFSRP5PR
Lot Numbers:
2007116 (Exp 2032-05-06)
UDI:
M684EFSRP5PR1

Implant has correct markings but may have incorrect packaging.

Product: EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY
Variants: Non-Porous, Size 6 Left Primary
Model / REF:
EFSRN6PL
Lot Numbers:
MP2002559 (Exp 2032-05-06)
UDI:
M684EFSRN6PL1

Implant has correct markings but may have incorrect packaging.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95672
Status: Active
Manufacturer: MicroPort Orthopedics Inc.
Sold By: hospitals; surgical centers; orthopedic clinics
Manufactured In: United States
Units Affected: 32
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.