Class II U.S. Food and Drug Administration

Encore Medical, LP Brand Name: Empowr 3D Knee Product Name: Empowr 3D Knee INS recall: Knee and Humeral socket implants contain incorrect labeling

Recall published 8 months ago

Knee and Humeral socket implants contain incorrect labeling.

The hazard: Mislabelling or misbranding

Misbranding prompted this recall. The agency treats a label that misstates the contents as seriously as it treats contamination, because people act on labels.

What the notice says: Knee and Humeral socket implants contain incorrect labeling.

Why it matters: The product carries the wrong label, the wrong lid or the wrong packaging. The food inside is generally fine; the problem is that the package describes something else, which defeats anyone relying on it.

Symptoms and when to call a doctor

There is no illness associated with mislabelling itself. The exception is where the undeclared contents include an allergen, in which case treat it as an allergen recall and watch for the reaction that person normally has.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-1459-2026
Published
March 4, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Encore Medical, LP
Product type
Medical devices
Units affected
14 implants
Distribution
Nationwide
Made in
United States
Lot / code info
Lot Code: Lot: 151T1055A GTIN: 00888912167147
UPC codes
00888912167147

Products covered by this recall

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00888912167147

Package size

Match the net weight or the piece count on the front of the pack.

  • 7 L

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Mislabelled

Encore Medical, LP — Misbranding prompted this recall. The agency treats a label that misstates the contents as seriously as it treats contamination, because people act on labels.

  1. Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.
  2. If the undeclared contents include an allergen, treat it as an allergen recall and stop serving it to anyone affected.
  3. Return it for a refund; a mislabelled pack is returnable whether or not it is edible for your household.
  4. Keep a photo of the mismatched label, which makes the refund conversation much shorter.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Company contact: Encore Medical, LP — 9800 Metric Blvd, Austin, TX, 78758-5445

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Encore Medical, LP medical devices recalled?

Knee and Humeral socket implants contain incorrect labeling. Knee and Humeral socket implants contain incorrect labeling.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00888912167147. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.

Can I get my money back?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

Where was the recalled product sold?

It was distributed nationwide.

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