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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

MicroPort Orthopedics Inc.: Evolution MP Femoral Knee Implants Recalled for Packaging Error

Agency Publication Date: July 1, 2024
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Summary

MicroPort Orthopedics Inc. has recalled 40 units of its EVOLUTION MP Femoral CS/CR Non-Porous knee replacement implants due to a packaging error where the wrong size and orientation of the device were found inside the box. One confirmed incident occurred where a surgeon opened a package labeled as a Size 4 Right femoral component only to find a Size 3 Left component inside. These specific implants are intended for cemented use in total knee replacement surgeries. Consumers should contact their healthcare provider or the manufacturer to determine if their implant is affected.

Risk

If an incorrect size or side (left versus right) of a knee implant is used or discovered during surgery, it can lead to surgical delays, improper joint fit, or the need for additional surgical procedures to correct the error. This packaging mismatch could cause serious complications if the surgeon does not identify the discrepancy before attempting to implant the device.

What You Should Do

  1. Check your surgical records or contact your orthopedic surgeon to determine if you received an Evolution MP Femoral CS/CR Non-Porous implant from the affected lots.
  2. Verify the identifying information: the affected products involve Part Number EFSRN4PR (Size 4 Right) which may actually contain Part Number EFSRN3PL (Size 3 Left).
  3. Look for the following identification numbers on the packaging if available: Lot Number MP1982170 (UDI M684EFSRN4PR1) or Lot Number MP1982097 (UDI M684EFSRN3PL1).
  4. If you are a healthcare provider, immediately quarantine any remaining field inventory of these specific lots and contact MicroPort Orthopedics Inc. for return instructions.
  5. Contact MicroPort Orthopedics Inc. or your healthcare provider for further instructions and information regarding potential next steps or refunds.
  6. For additional questions or to report complications, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Manufacturer Notification

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund.

Affected Products

Product: EVOLUTION MP Femoral CS/CR Non-Porous (Size 4 Right)
Model / REF:
EFSRN4PR
UPC Codes:
M684EFSRN4PR1
Lot Numbers:
MP1982170
Product: EVOLUTION MP Femoral CS/CR Non-Porous (Size 3 Left)
Model / REF:
EFSRN3PL
UPC Codes:
M684EFSRN3PL1
Lot Numbers:
MP1982097

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94729
Status: Active
Manufacturer: MicroPort Orthopedics Inc.
Sold By: International distribution; China
Manufactured In: United States
Units Affected: 40 units

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 · 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.