EMPOWR 3D Knee Tibial Inserts Recalled for Packaging Discrepancy

Agency Publication Date: July 17, 2025

Summary

Encore Medical, LP is recalling 20 units of EMPOWR 3D Knee Tibial Inserts (E-PLUS) because the packages may contain the incorrect tibial implants. If a surgeon unknowingly selects and uses the incorrect part during a knee replacement procedure, the implant may not fit or function correctly. This defect could result in the need for a follow-up revision surgery to correct the error.

Risk

The use of an incorrectly sized or shaped tibial insert can cause implant failure or improper joint mobility, potentially requiring a second surgery (revision surgery) to replace the device. No injuries or incidents have been reported at this time.

What You Should Do

The recalled products are EMPOWR 3D Knee Tibial Inserts - E-PLUS with model numbers 341-10-711 (10mm size) and 341-12-711 (12mm size).
Identify affected units by checking the packaging for lot codes 071T1084 or 115T1077, and GTINs 00888912166881 or 00888912166980.
Stop using the recalled inserts immediately and quarantine any matching products to prevent them from being used in surgeries.
Contact Encore Medical, LP or your authorized distributor to arrange for the return and replacement of the affected units.
For additional questions, call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices.

Your Remedy Options

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 - E-PLUS (11L 10MM, VE)

Variants: 11L 10MM, VE

Model / REF:

341-10-711

Lot Numbers:

071T1084

GTIN:

00888912166881

Quantity: 20 units

Product: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS (11L 12MM, VE)

Variants: 11L 12MM, VE

Model / REF:

341-12-711

Lot Numbers:

115T1077

GTIN:

00888912166980

Quantity: 20 units

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97048

Status: Active

Manufacturer: Encore Medical, LP

Sold By: Hospitals; Surgical Centers

Manufactured In: United States

Units Affected: 2 products (20)

Distributed To: Arizona, Iowa, Idaho, Illinois, Indiana, Louisiana, Michigan, Missouri, Mississippi, Nebraska, New York, Oklahoma, Oregon, Puerto Rico, South Dakota, Utah, Virginia, Washington

Agency Last Updated: July 18, 2025

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.

Summary

What You Should Do

The recalled products are EMPOWR 3D Knee Tibial Inserts - E-PLUS with model numbers 341-10-711 (10mm size) and 341-12-711 (12mm size).

Identify affected units by checking the packaging for lot codes 071T1084 or 115T1077, and GTINs 00888912166881 or 00888912166980.

Stop using the recalled inserts immediately and quarantine any matching products to prevent them from being used in surgeries.

Contact Encore Medical, LP or your authorized distributor to arrange for the return and replacement of the affected units.

For additional questions, call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices.

Affected Products

Product: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS (11L 10MM, VE)

Variants: 11L 10MM, VE

Model / REF:

341-10-711

Lot Numbers:

071T1084

GTIN:

00888912166881

Quantity: 20 units

Product: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS (11L 12MM, VE)

Variants: 11L 12MM, VE

Model / REF:

341-12-711

Lot Numbers:

115T1077

GTIN:

00888912166980

Quantity: 20 units

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97048

Status: Active

Manufacturer: Encore Medical, LP

Sold By: Hospitals; Surgical Centers

Manufactured In: United States

Units Affected: 2 products (20)

Distributed To: Arizona, Iowa, Idaho, Illinois, Indiana, Louisiana, Michigan, Missouri, Mississippi, Nebraska, New York, Oklahoma, Oregon, Puerto Rico, South Dakota, Utah, Virginia, Washington

Agency Last Updated: July 18, 2025