Encore Medical, LP: EMPOWR Porous Knee Systems Recalled for Incorrect Device Packaging

Agency Publication Date: December 7, 2023

Summary

Encore Medical, LP is recalling 37 units of the DJO surgical EMPOWR Porous Knee System, specifically the 3D Matrix Coated Femur and Press Fit components. The recall was initiated because the packages contain the incorrect surgical device, which may lead to delays in surgery or the implantation of an unintended component. This issue affects specific models and lot numbers of the Size 8 Left knee system used for knee replacement surgeries (arthroplasty).

Risk

If an incorrect device is identified during surgery, it could lead to a surgical delay while a replacement is sourced. If an incorrect device were implanted, it could result in improper fit, joint instability, or the need for a revision surgery to correct the error.

What You Should Do

Identify if you have the affected products by checking for Model Number 243-01-108 with Lot Number 277W1114 (UDI-DI 00190446231295).
Check for the second affected product: Model Number 353-03-108 with Lot Number 213W1051 (UDI-DI 00190446231295).
Healthcare providers and facilities should immediately stop using these specific lots and quarantine the products to prevent use in surgeries.
Contact your Encore Medical (DJO Surgical) representative or the manufacturer directly at 1-800-456-8696 to arrange for the return of the incorrect devices.
If you are a patient who has recently undergone a knee replacement involving the EMPOWR system and have concerns, contact your surgeon or healthcare provider to discuss your procedure.
For further information or to report concerns, 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 and device return

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

Affected Products

Product: DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED

Model / REF:

243-01-108

UPC Codes:

00190446231295

Lot Numbers:

277W1114

Product: DJO surgical EMPOWR KNEE, PRESS FIT BP MINUS, 8L

Model / REF:

353-03-108

UPC Codes:

00190446231295

Lot Numbers:

213W1051

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93465

Status: Active

Manufacturer: Encore Medical, LP

Sold By: Authorized medical distributors; Direct hospital sales

Manufactured In: United States

Units Affected: 37 devices

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 · 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 affected products by checking for Model Number 243-01-108 with Lot Number 277W1114 (UDI-DI 00190446231295).

Check for the second affected product: Model Number 353-03-108 with Lot Number 213W1051 (UDI-DI 00190446231295).

Healthcare providers and facilities should immediately stop using these specific lots and quarantine the products to prevent use in surgeries.

Contact your Encore Medical (DJO Surgical) representative or the manufacturer directly at 1-800-456-8696 to arrange for the return of the incorrect devices.

If you are a patient who has recently undergone a knee replacement involving the EMPOWR system and have concerns, contact your surgeon or healthcare provider to discuss your procedure.

For further information or to report concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED

Model / REF:

243-01-108

UPC Codes:

00190446231295

Lot Numbers:

277W1114

Product: DJO surgical EMPOWR KNEE, PRESS FIT BP MINUS, 8L

Model / REF:

353-03-108

UPC Codes:

00190446231295

Lot Numbers:

213W1051