EMPOWR 3D Knee Tibial Insert 5R 14MM recall (Encore Medical, LP)
Medical deviceClass IIOngoing
Summary: Encore Medical, LP is recalling EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705. Reason: 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
What is being recalled
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Why
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
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: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA (states named: Alabama, California, Iowa, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Texas)
How to tell if yours is affected
UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026
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-1233-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 5, 2026 |
| Reported | February 11, 2026 |
| Company | Encore Medical, LP |
| Company location | Austin, TX, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 19 |
More recalls from Encore Medical, LP · all medical device recalls · recalls from January 2026