Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
“EMPOWR 3D Knee Insert Recall: Incorrect Product Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52165-empowr-3d-knee-insert-recall-incorrect-product-risk. Based on FDA recall #Z-2126-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2126-2025%22&limit=1).
Encore Medical, LP recalled the EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS due to a packaging discrepancy that may result in incorrect implants being selected. The Food and Drug Administration announced the voluntary Class II recall on June 2, 2025.
How to tell if you have it
Brand: Encore Medical
Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE
Model/Catalog Number: 341-12-711
UPC: 00888912166980
Lot Code: 115T1077
The hazard
The recall is due to a packaging discrepancy with incorrect tibial inserts being packaged. The use of this product may result in the incorrect product being selected, which could result in a revision surgery if used.
Context
GovInfoNow's records show Encore Medical, LP has 43 other recalls on record since May 31, 2017. Recent similar recalls include an EMPOWR 3D KNEE Ins 11L 14MM VE packaging mix-up (Feb. 16, 2026) and an EMPOWR 3D KNEE Implants incorrect labeling notice (Jan. 15, 2026). Other recent recalls of similar products include a U2 Total Knee System Femoral Offset Bushing recall (March 19, 2026), a Howmedica TRIATHLON Hinge Insert recall (July 30, 2026), and a U2 Total Knee System Femoral Valgus Adaptor recall (May 20, 2026).
How to tell if you have this one
Check for the model number 341-12-711 on the packaging. The product was sold with lot code 115T1077 and software version NA.
Brand
Encore Medical
Product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog
Category
Medical device
FDA recall event · 2 products
All 2 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
U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA
Recall number
Product, codes & lots
Z-2125-2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA; Lot Code: Item: 341-10-711 GTIN: 00888912166881 Lot\s: 071T1084
Z-2126-2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA; Lot Code: Item: 341-12-711 GTIN: 00888912166980 Lot: 115T1077
Based on the official FDA remedy
What to do — step by step
Check Product Packaging
Look for the model number 341-12-711 and lot code 115T1077 on the packaging to confirm if it's the recalled item.
Where it went and when
Where it was distributed
Distributed in 17 states and Puerto Rico.
Listed by the agency
Not listed
FDA distribution: “U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Idaho, Illinois, Indiana, Iowa, Louisiana, Michigan, Mississippi, Missouri, Nebraska, New York, Oklahoma, Oregon, Puerto Rico, South Dakota, Utah, Virginia, Washington.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2126-2025 (June 2, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2126-2025 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.