HIGH

Encore Medical Recalls EMPOWR 3D Knee Implants Due to Labeling Issues

Encore Medical, LP recalled 14 EMPOWR 3D Knee implants on January 15, 2026. The implants contain incorrect labeling that poses a risk to patients. Healthcare providers should stop using the device immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
January 15, 2026
Hazard Level
HIGH
Brand
Encore Medical, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Knee and Humeral socket implants contain incorrect labeling.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Encore Medical, LP or your healthcare provider for instructions. Notification method: Letter

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About This Product

The EMPOWR 3D Knee implant is designed for patients requiring knee replacement surgery. Surgeons and healthcare providers choose this product for its advanced design and compatibility with various surgical techniques.

Why This Is Dangerous

Incorrect labeling on the knee and humeral socket implants can result in improper usage, potentially leading to ineffective treatment or adverse effects.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients may face delays in necessary treatments while addressing the recall, potentially affecting their recovery timeline.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on your implant to confirm if it is 341-16-707.
  2. Verify the lot code against the recalled lot code 151T1055A.
  3. Contact your healthcare provider for assistance in identifying affected products.

Where to find product info

The model number and lot code can typically be found on the packaging or the implant itself, as indicated by your surgeon.

What timeline to expect

Expect a response or instruction from Encore Medical within a few weeks after reporting the recall.

If the manufacturer is unresponsive

  • Document all attempts to contact the manufacturer.
  • Reach out to your healthcare provider for assistance.
  • Consider filing a complaint with the FDA if unresponsive.

How to prevent similar issues

  • Inquire about labeling and safety certifications when selecting medical devices.
  • Stay informed about product recalls related to medical implants.
  • Discuss with your healthcare provider any concerns about the devices being used.

Documentation advice

Keep copies of all correspondence with Encore Medical and your healthcare provider, including any instructions you receive regarding the recall.

Product Details

The recalled product is the EMPOWR 3D KNEE INS, 7L 16MM, VE with model number 341-16-707. The affected lot code is Lot: 151T1055A and GTIN: 00888912167147. This product was distributed nationwide across several states, including Virginia, Tennessee, and California.

Key Facts

  • Recall date: January 15, 2026
  • 14 implants involved
  • Class II recall status
  • Distributed in 15 states across the US
  • Immediate action required for patients and providers

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot Code: Lot: 151T1055A GTIN: 00888912167147
Affected States
ALL
Report Date
March 4, 2026
Recall Status
ACTIVE

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