FDA recall, , Moderate risk
Encore Medical EMPOWR 3D Knee Implants
The knee device has a packaging discrepancy with incorrect product size mixed up.
Summary by Recall Canary from the FDA notice
What happened
Encore Medical, LP, of Austin, Texas, recalled Empowr 3D Knee Ins due to a packaging discrepancy with incorrect product size mixed up. The recall began February 16, 2026, and was added to the FDA's Enforcement Report on July 8, 2026. The affected products include Empowr 3D Knee Ins models 341-14-711 and 342-19-703, which are intended for knee arthroplasty.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match your product and all the details in one listed combination.
A UDI-DI is the device identifier printed with the barcode on the device label.
Empowr 3D Knee INS, 11L 14MM, VE
- UDI-DI
- 00888912167086
- Model/Catalog number
- 341-14-711
- Lot code
- 145T1067
- 135T1060
- UDI-DI
- 00888912167703
- Model/Catalog number
- 342-19-703
- Lot code
- 177T1057
Recall details
- Company began the recall
- Sold in
GL112 Certus Medical LLC Indiana (Indiana) & Michigan (Michigan) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 MW001 Fox Medtech, LLC Colorado (Colorado), Wyoming (Wyoming), Montana (Montana), Counties in Nebraska 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 Nebraska190 Implant Medical Sales, Inc. New York (New York) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 SE180 Joint Medical Solutions, L.L.C. Alabama (Alabama) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 GL108 Great Lakes Medical Illiniois (Illinois) 341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 2 GL112 Certus Medical LLC Indiana (Indiana) & Michigan (Michigan) 341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 1 CE120 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, Texas 342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1 NW105 Kinetic Medicine South Dakota (South Dakota), Eastern Nebraska (Nebraska), Western Iowa (Iowa) 342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 2 MA102 ProCore Medical LLC - North Carolina North Carolina (North Carolina) 342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1 Total 11
- Company
- Encore Medical, LPAustin, Texas
- Hazard
- Packaging defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98700
- Recall numbers
- Z-2700-2026 to Z-2701-2026
All recalls from Encore Medical, LP
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
