Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS recall (Encore Medical, LP)
Medical deviceClass IIOngoing
Summary: Encore Medical, LP is recalling Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707. Reason: Knee and Humeral socket implants contain incorrect labeling.
What is being recalled
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Why
Knee and Humeral socket implants contain incorrect labeling.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA. (states named: California, Colorado, Florida, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Missouri, Montana, New Jersey, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Virginia, Wyoming)
How to tell if yours is affected
Lot Code: Lot: 151T1055A GTIN: 00888912167147
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1459-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 15, 2026 |
| Reported | March 4, 2026 |
| Company | Encore Medical, LP |
| Company location | Austin, TX, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 14 implants |
More recalls from Encore Medical, LP · all medical device recalls · recalls from January 2026