Encore Medical, LP: EMPOWR Knee Inserts and Hip Liners Recalled for Mislabeled Packaging

Agency Publication Date: October 12, 2023

Summary

Encore Medical, LP is recalling 56 units of EMPOWR 3D Knee Tibial Inserts and EMPOWR Acetabular System Hip Liners because the products were swapped inside their packaging before being sealed. This defect means a package labeled for a knee surgery could actually contain a hip replacement part and vice versa. Using the wrong component during surgery could lead to significant surgical delays or the inability to complete the procedure properly due to the vast differences between hip and knee anatomy.

Risk

The incorrect product may be provided to a surgeon during an operation, leading to surgical delays, extended anesthesia time, or the risk of using an incompatible implant if the error is not caught before insertion.

What You Should Do

Identify if you have the EMPOWR 3D Knee Tibial Insert (REF: 342-10-705) by checking for UDI-DI 00888912167321 and Lot 075T1167 with an expiration date of March 30, 2028.
Identify if you have the EMPOWR Acetabular System Liner (REF: 942-01-40H) by checking for UDI-DI 00190446309833 and Lot 629Z1114 with an expiration date of March 30, 2028.
Immediately stop using these specific lots and set them aside to ensure they are not used in surgical procedures.
Contact your healthcare provider or Encore Medical, LP (DJO Global) at 9800 Metric Blvd, Austin, Texas, 78758-5445 for further instructions and potential refund or replacement.
Healthcare professionals should contact the manufacturer to arrange for the return of any affected inventory.
For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact manufacturer for instructions.

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

Affected Products

Product: EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705

Model / REF:

342-10-705

UPC Codes:

00888912167321

Lot Numbers:

075T1167 (Exp March 30, 2028)

Date Ranges: Expiration: March 30, 2028

Product: EMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40H

Model / REF:

942-01-40H

UPC Codes:

00190446309833

Lot Numbers:

629Z1114 (Exp March 30, 2028)

Date Ranges: Expiration: March 30, 2028

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93098

Status: Active

Manufacturer: Encore Medical, LP

Manufactured In: United States

Units Affected: 2 products (36; 20)

Distributed To: Florida, California, Indiana, Hawaii, Louisiana, Minnesota, Arizona, Texas, New Jersey, Pennsylvania, Kansas, Tennessee, Puerto Rico, South Carolina, 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 · 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

Identify if you have the EMPOWR 3D Knee Tibial Insert (REF: 342-10-705) by checking for UDI-DI 00888912167321 and Lot 075T1167 with an expiration date of March 30, 2028.

Identify if you have the EMPOWR Acetabular System Liner (REF: 942-01-40H) by checking for UDI-DI 00190446309833 and Lot 629Z1114 with an expiration date of March 30, 2028.

Immediately stop using these specific lots and set them aside to ensure they are not used in surgical procedures.

Contact your healthcare provider or Encore Medical, LP (DJO Global) at 9800 Metric Blvd, Austin, Texas, 78758-5445 for further instructions and potential refund or replacement.

Healthcare professionals should contact the manufacturer to arrange for the return of any affected inventory.

For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705

Model / REF:

342-10-705

UPC Codes:

00888912167321

Lot Numbers:

075T1167 (Exp March 30, 2028)

Date Ranges: Expiration: March 30, 2028

Product: EMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40H

Model / REF:

942-01-40H

UPC Codes:

00190446309833

Lot Numbers:

629Z1114 (Exp March 30, 2028)

Date Ranges: Expiration: March 30, 2028

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93098

Status: Active

Manufacturer: Encore Medical, LP

Manufactured In: United States

Units Affected: 2 products (36; 20)

Distributed To: Florida, California, Indiana, Hawaii, Louisiana, Minnesota, Arizona, Texas, New Jersey, Pennsylvania, Kansas, Tennessee, Puerto Rico, South Carolina, Washington