EMPOWR 3D Knee Insert E-Plus: Incorrect Labeling Risk

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Encore Medical is recalling EMPOWR 3D Knee TIBIAL INSERT E-Plus models with incorrect labeling of size and side. This could cause improper fitting during knee replacement surgery, potentially leading to complications.

Why it’s dangerous

The knee implant has incorrect labeling of size and side, which could lead to improper fitting during surgery. This might cause complications such as misalignment or improper joint function after the procedure.

Who’s affected

Patients who received the EMPOWR 3D Knee TIBIAL INSERT E-Plus (model 341-16-704) during knee replacement surgery are affected. Surgeons and medical staff who used this model are most at risk.

How to tell if you have this one

Check for the model number 341-16-704 on the product label. This specific knee implant was sold with lot code 148T1057.

Brand
Encore Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the model number 341-16-704 on the implant label.

✎ GovInfoNow

Questions people ask

What is the model number of the recalled knee implant?

The model number is 341-16-704.

Why is this implant being recalled?

The implant has incorrect labeling of size and side, which could lead to improper fitting during surgery.

How can I tell if I have the recalled product?

Check for the model number 341-16-704 on the product label. This specific implant was sold with lot code 148T1057.

Take action

Contact Encore Medical

We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2285-2025 — Encore Medical Encore Medical

Hello,

I own a Encore Medical that is covered by recall Z-2285-2025 from Encore Medical.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-2285-2025 (July 9, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2285-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.

Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number:

Lower-risk recall