Lower risk Medical device recall · FDA · Published August 4, 2023

DJO Surgical Empowr Knee Recall: Infection Risk from Unsterilized Components

DJO Surgical recalls Empowr Knee and Universal Tibia Baseplate models due to unsterilized components that may cause infection after implant. Affected units have specific UDI-DI/Lot/Expiration codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2603-2023Medical device DJO Surgical ›

Lower-risk recall

Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery

Take action

Contact the company

Recalling firmEncore Medical, LP9800 Metric Blvd · Austin, TX 78758-5445

✎ GovInfoNow plain-language explainer

DJO Surgical is recalling Empowr Knee and Universal Tibia Baseplate models because their components weren't properly sterilized before shipping. If implanted, this could lead to infections requiring treatment, monitoring, and possible revision surgery. Read more at govinfonow.com/recall/57535-djo-surgical-empowr-knee-recall-infection-risk-from-unsterilized-components.

Source Summary by GovInfoNow · govinfonow.com/recall/57535-djo-surgical-empowr-knee-recall-infection-risk-from-unsterilized-components · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2603-2023

Cite this page

“DJO Surgical Empowr Knee Recall: Infection Risk from Unsterilized Components.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57535-djo-surgical-empowr-knee-recall-infection-risk-from-unsterilized-components. Based on FDA recall #Z-2603-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2603-2023%22&limit=1).

Encore Medical, LP voluntarily recalled DJO Surgical Empowr Knee and Universal Tibia Baseplate components on Aug. 4, 2023, because they lacked final sterilization, the FDA said. The hazard is potential infection requiring treatment or revision surgery.

How to tell if you have it

Brand: DJO Surgical
Product: Empowr Knee, Universal Tibia Baseplate, 6R
REF: 352-02-106
UDI-DI/Lot/Expiration: 00190446258032/308V1112/May 25, 2029
Quantity: 20 units

The hazard

The orthopedic device components were not subjected to final sterilization before shipment. If implanted, this may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery.

Context

GovInfoNow's records show Encore Medical, LP has 43 other recalls on record since May 31, 2017. Other recent recalls include the EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up Recall (Feb. 16, 2026), the Encore Medical RSP Humeral Socket Insert Recall (Jan. 15, 2026), and the Encore Medical EMPOWR Acetabular System Recall (Jan. 5, 2026). Other recent recalls of similar products include Medline Recalls Knee Surgery Kits Due to Sterility Risk (June 10, 2026) and Depuy ATTUNE Revision Hinge Knee Components May Compromise Sterility (May 19, 2026).

How to tell if you have this one

Check for the UDI-DI/Lot/Expiration code 00190446258032/308V1112 on the product with the expiration date May 25, 2029. The recalled models are Empowr Knee and Universal Tibia Baseplate, 6R, REF: 352-02-106.

Brand
DJO Surgical
Category
Medical device

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France, UK, Colombia, Germany

Recall number	Product, codes & lots	Quantity
Z-2603-2023	DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106; UDI-DI/Lot/Expiration: 00190446258032/308V1112/May 25, 2029	20
Z-2604-2023	DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443; UDI-DI/Lot/Expiration: 00888912076210/878B1171/May 2, 2027	10
Z-2605-2023	DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030; UDI-DI/Lot/Expiration: 00888912079631/415N1014/May 3, 2028	0
Z-2606-2023	DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm, REF: 508-36-101; REF/UDI-DI/Lot/Expiration: 508-01-032/00888912024693/859C1190/April 29, 2027; 508-32-104/00888912024754/866C3153/May 25, 2029 and 866C3147/April 3, 2029; 508-36-101/869C3539/April 30, 2028	64
Z-2607-2023	DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108; UDI-DI/Lot: 00190446259091/923W1411/April 3, 2029	15

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the UDI-DI/Lot/Expiration code 00190446258032/308V1112 with expiration May 25, 2029 on the Empowr Knee or Universal Tibia Baseplate, 6R model.

Where it went and when

Where it was distributed

Distributed in 25 states and Puerto Rico, and outside the U.S.

FDA distribution: “US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France, UK, Colombia, Germany” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington.

Recall timeline

FDA published this recall 54 days after the firm started it.

Aug 4, 2023Firm started the recall
Sep 19, 2023FDA classified it Class II
Sep 27, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of serious injury from this product?

The hazard is infection risk after implantation, which may require treatment and revision surgery, but does not cause immediate serious injury in normal use.

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Link to this recall

<a href="https://govinfonow.com/recall/57535-djo-surgical-empowr-knee-recall-infection-risk-from-unsterilized-components">DJO Surgical Empowr Knee Recall: Infection Risk from Unsterilized Components (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2603-2023 (August 4, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2603-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.