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Lower risk Medical device recall · FDA · Published December 10, 2024

Encore Medical EMPOWR 3D Knee Insert May Cause Surgical Delay

Encore Medical recalls EMPOWR 3D Knee Tibial Insert 6R 10MM model due to potential surgical delay from an acetabular system in the package.

🇺🇸 FDA recall #Z-0761-2025Medical deviceEncore Medical ›
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Recalling firmEncore Medical, LP9800 Metric Blvd · Austin, TX 78758-5445
✎ GovInfoNow plain-language explainer

Encore Medical is recalling their EMPOWR 3D Knee Tibial Insert 6R 1:00MM model because the packaging might contain an acetabular system that could delay surgery for a new product. This recall affects patients who have this specific knee implant. Read more at govinfonow.com/recall/53318-encore-medical-empowr-3d-knee-insert-may-cause-surgical-delay.

Source Summary by GovInfoNow · govinfonow.com/recall/53318-encore-medical-empowr-3d-knee-insert-may-cause-surgical-delay · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0761-2025

Cite this page

“Encore Medical EMPOWR 3D Knee Insert May Cause Surgical Delay.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53318-encore-medical-empowr-3d-knee-insert-may-cause-surgical-delay. Based on FDA recall #Z-0761-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0761-2025%22&limit=1).

The FDA announced on Dec. 10, 2024, that Encore Medical, LP is recalling the EMPOWR 3D Knee Tibial Insert because packages may contain an acetabular system. This error may cause surgical delays while obtaining a replacement product.

How to tell if you have it

  • Brand: Encore Medical
  • Product: EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE
  • REF: 342-10-706
  • UDI-DI: 00888912167338
  • Lot: 076T1273A
  • Quantity: 9 units
  • Sold: US Nationwide in IN, KS, CA, FL, NY, TX, AL, WA

The hazard

The knee insert package may contain an acetabular system. This mix-up may cause surgical delay to get a new product.

Context

GovInfoNow's records show Encore Medical, LP has issued 43 other recalls since May 31, 2017. Recent company actions include the Feb. 16, 2026 EMPOWR 3D Knee Ins Product Mix-Up Recall and the Jan. 15, 2026 RSP Humeral Socket Insert Recall for incorrect labeling. Other recent recalls of similar products include the May 20, 2026 U2 Total Knee System assembly risk and the May 19, 2026 Depuy ATTUNE Revision Hinge sterility risks.

How to tell if you have this one

Check for the model number 6R 10MM, part number REF: 342-10-706, and lot number 076T1273A on the packaging. The product was sold with a UDI-DI code 00888912167338.

  • Brand
    Encore Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Package Details

    Look for the model number 6R 10MM, part number REF: 342-10-706, and lot number 076T1273A on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 8 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Florida, Indiana, Kansas, New York, Texas, Washington.

Recall timeline

FDA published this recall 22 days after the firm started it.

1. Firm started the recall: Dec 10, 202412. FDA classified it Class II: Dec 23, 202423. Published in FDA’s Enforcement Report: Jan 1, 2025320242025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-0761-2025 (December 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0761-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA