← FDA ENFORCEMENT
Z-2701-2026Class II

Encore Medical, LP

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Encore Medical, LP
Product type
Device
Status
Ongoing
Report date
2026-07-15
Distribution
GL112 Certus Medical LLC Indiana (IN) & Michigan (MI) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 MW001 Fox Medtech, LLC Colorado (CO), Wyoming (WY), Montana (MT), Counties in Nebraska 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 NE190 Implant Medical Sales, Inc. New York (NY) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 SE180 Joint Medical Solutions, L.L.C. Alabama (AL) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 GL108 Great Lakes Medical Illiniois (IL) 341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 2 GL112 Certus Medical LLC Indiana (IN) & Michigan (MI) 341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 1 CE120 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX 342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1 NW105 Kinetic Medicine South Dakota (SD), Eastern Nebraska (NE), Western Iowa (IA) 342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 2 MA102 ProCore Medical LLC - NC North Carolina (NC) 3
Firm state
TX
Product quantity
8
Initiated by
Voluntary: Firm initiated
Reason for recall

Due to packaging discrepancy with incorrect product size mixed up.

Product description

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.

Code / lot info

Model/Catalog Number: 341-14-711 Lot Code: Lot: 145T1067 and 135T1060 GTIN: 00888912167086 Expiration Date: 12-06-2026 (145T1067) 12-07-2026 (135T1060)

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →