Encore Medical, LP

FDA Regulatory Profile

Summary

Total Recalls
97
510(k) Clearances
2
Inspections
8
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1460-2026Class IIBrand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MJanuary 15, 2026
Z-1459-2026Class IIBrand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341January 15, 2026
Z-1458-2026Class IIBrand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, SJanuary 15, 2026
Z-1233-2026Class IIEMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705January 5, 2026
Z-1234-2026Class IIEMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree HoodJanuary 5, 2026
Z-2549-2025Class IIBrand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: NoJuly 18, 2025
Z-2548-2025Class IIBrand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog July 18, 2025
Z-2546-2025Class IIBrand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog NuJuly 18, 2025
Z-2547-2025Class IIBrand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm ModJuly 18, 2025
Z-2285-2025Class IIBrand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE ModeJuly 9, 2025
Z-2286-2025Class IIBrand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE ModeJuly 9, 2025
Z-2147-2025Class IIBrand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID2June 12, 2025
Z-2148-2025Class IIBrand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID2June 12, 2025
Z-2126-2025Class IIBrand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE June 2, 2025
Z-2125-2025Class IIBrand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE June 2, 2025
Z-2009-2025Class IIBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/CataMay 28, 2025
Z-2010-2025Class IIBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/CataMay 28, 2025
Z-2011-2025Class IIBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/CataMay 28, 2025
Z-2008-2025Class IIBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/CataMay 28, 2025
Z-0766-2025Class IIEMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, December 18, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K223779EMPOWR™ blade stemFebruary 13, 2023
K052086ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTERAugust 31, 2005