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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

EMPOWR 3D Knee Tibial Inserts Recalled for Incorrect Package Contents

Agency Publication Date: December 23, 2024
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Summary

This recall affects 9 units of the EMPOWR 3D Knee Tibial Insert (REF: 342-10-706), which is used in knee replacement procedures. The package for these knee inserts may incorrectly contain an acetabular system, which is a component used in hip surgeries. No injuries have been reported, but this mix-up can cause surgical delays while medical staff obtain the correct product.

Risk

The presence of an incorrect medical component inside the packaging can lead to a delay in surgery while a replacement is found. This may result in the patient spending a longer time under anesthesia than originally planned.

What You Should Do

  1. This recall affects EMPOWR 3D Knee Tibial Inserts (REF: 342-10-706) with Lot number 076T1273A and UDI-DI 00888912167338.
  2. Stop using the recalled device immediately.
  3. Contact Encore Medical, LP or your distributor to arrange for the return, replacement, or correction of the affected product.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

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: EMPOWR 3D Knee Tibial Insert
Variants: 6R 10MM, VE
Model / REF:
342-10-706
Lot Numbers:
076T1273A
UDI:
00888912167338

Recall #: Z-0761-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95882
Status: Active
Manufacturer: Encore Medical, LP
Sold By: hospitals; surgical centers
Manufactured In: United States
Units Affected: 9
Distributed To: Indiana, Kansas, California, Florida, New York, Texas, Alabama, Washington

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.