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Encore Medical, LP

151 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Nu recall (Z-2700-2026)Encore Medical, LP2026-07-08
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Nu recall (Z-2701-2026)Encore Medical, LP2026-07-08
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32M recall (Z-1458-2026)Encore Medical, LP2026-02-24
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Num recall (Z-1459-2026)Encore Medical, LP2026-02-24
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET IN recall (Z-1460-2026)Encore Medical, LP2026-02-24
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 recall (Z-1233-2026)Encore Medical, LP2026-02-02
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 d recall (Z-1234-2026)Encore Medical, LP2026-02-02
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Ca recall (Z-2546-2025)Encore Medical, LP2025-09-10
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6 recall (Z-2547-2025)Encore Medical, LP2025-09-10
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/ recall (Z-2548-2025)Encore Medical, LP2025-09-10
Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Nu recall (Z-2549-2025)Encore Medical, LP2025-09-10
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16M recall (Z-2285-2025)Encore Medical, LP2025-08-08
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16M recall (Z-2286-2025)Encore Medical, LP2025-08-08
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bea recall (Z-2147-2025)Encore Medical, LP2025-07-21
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bea recall (Z-2148-2025)Encore Medical, LP2025-07-21
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L recall (Z-2125-2025)Encore Medical, LP2025-07-17
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L recall (Z-2126-2025)Encore Medical, LP2025-07-17
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Mo recall (Z-2008-2025)Encore Medical, LP2025-06-23
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Mo recall (Z-2009-2025)Encore Medical, LP2025-06-23
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Mo recall (Z-2010-2025)Encore Medical, LP2025-06-23
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Mo recall (Z-2011-2025)Encore Medical, LP2025-06-23
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, recall (Z-0766-2025)Encore Medical, LP2024-12-26
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706 recall (Z-0761-2025)Encore Medical, LP2024-12-23
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Cons recall (Z-0625-2024)Encore Medical, LP2024-01-02
REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2 recall (Z-0626-2024)Encore Medical, LP2024-01-02
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device. recall (Z-0532-2024)Encore Medical, LP2023-12-12
DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX recall (Z-0508-2024)Encore Medical, LP2023-12-07
RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, o recall (Z-0281-2024)Encore Medical, LP2023-11-08
RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic sh recall (Z-0282-2024)Encore Medical, LP2023-11-08
DJO EMPOWR Knee Punch Handle, REF: 801-05-040 recall (Z-0258-2024)Encore Medical, LP2023-11-07
REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-1 recall (Z-0098-2024)Encore Medical, LP2023-10-12
EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705 recall (Z-0102-2024)Encore Medical, LP2023-10-12
EMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40H recall (Z-0103-2024)Encore Medical, LP2023-10-12
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 recall (Z-2603-2023)Encore Medical, LP2023-09-19
DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443 recall (Z-2604-2023)Encore Medical, LP2023-09-19
DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-03 recall (Z-2605-2023)Encore Medical, LP2023-09-19
DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01- recall (Z-2606-2023)Encore Medical, LP2023-09-19
DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108 recall (Z-2607-2023)Encore Medical, LP2023-09-19
EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 80 recall (Z-1384-2023)Encore Medical, LP2023-04-12
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSER recall (Z-1187-2023)Encore Medical, LP2023-02-27
EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic impl recall (Z-0125-2023)Encore Medical, LP2022-10-21
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component. recall (Z-0126-2023)Encore Medical, LP2022-10-21
DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instru recall (Z-0060-2021)Encore Medical, LP2020-10-07
EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PA recall (Z-0611-2020)Encore Medical, Lp2019-12-06
AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qt recall (Z-1241-2018)Encore Medical, Lp2018-03-05
Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS recall (Z-0064-2018)Encore Medical, Lp2017-11-06
Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS recall (Z-0065-2018)Encore Medical, Lp2017-11-06
Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, M recall (Z-0066-2018)Encore Medical, Lp2017-11-06
Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, M recall (Z-0067-2018)Encore Medical, Lp2017-11-06
LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Fe recall (Z-1191-2017)Encore Medical, Lp2017-02-11
Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from H recall (Z-1139-2017)Encore Medical, Lp2017-02-03
Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-meas recall (Z-2606-2016)Encore Medical, Lp2016-08-19
MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636 recall (Z-2242-2016)Encore Medical, Lp2016-07-19
AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number recall (Z-0626-2016)Encore Medical, Lp2016-01-09
Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt recall (Z-0165-2016)Encore Medical, Lp2015-10-26
AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is inten recall (Z-0131-2016)Encore Medical, Lp2015-10-16
FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139 recall (Z-2262-2015)Encore Medical, Lp2015-07-27
3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise recall (Z-1213-2013)Encore Medical, Lp2013-05-02
6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell o recall (Z-0139-2013)Encore Medical, Lp2012-10-25
3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, S recall (Z-2302-2012)Encore Medical, Lp2012-08-30
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of t recall (Z-2146-2012)Encore Medical, Lp2012-08-06
FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R CEMENTED Sz 16.5mm DJO Surgical 9800 M recall (Z-0418-2012)Encore Medical, Lp2012-01-11
Foundation Tibial Broach P/N 801-01-013 Foundation Tibial Broach to be used in conjunction recall (Z-0349-2012)Encore Medical, Lp2011-12-02
RSP Humeral Socket Reamer (Size 32 SML): DJO Surgical Instruments and Instrument Cases DJO recall (Z-0150-2012)Encore Medical, Lp2011-11-02
RSP Baseplate Rim Planer (Size 32, 36, 40): DJO Surgical Instruments and Instrument Cases recall (Z-0151-2012)Encore Medical, Lp2011-11-02
Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, recall (Z-2739-2011)Encore Medical, Lp2011-07-06
Foundation Knee System Instrumentation, Tibial Broach Assembly. Used in conjunction with t recall (Z-2734-2011)Encore Medical, Lp2011-07-05
CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medi recall (Z-0828-2011)Encore Medical, Lp2010-12-28
Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical recall (Z-0798-2011)Encore Medical, Lp2010-12-22
Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical recall (Z-0799-2011)Encore Medical, Lp2010-12-22
Turon Shoulder System Instrumentation, Turon Trial Pegged Glenoid, DJO Surgical recall (Z-0800-2011)Encore Medical, Lp2010-12-22
Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, D recall (Z-0801-2011)Encore Medical, Lp2010-12-22
Glenoid Head Inserter (RSP Inserter/Impactor), Device Part #804-03-041, All Lots. Product recall (Z-2636-2010)Encore Medical, Lp2010-09-30
3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003. recall (Z-2244-2010)Encore Medical, Lp2010-08-22
MIKA Speedblock, Size 8-12. The MIKA Speedblock is placed on the distal femur as a guide f recall (Z-2164-2010)Encore Medical, Lp2010-08-02
3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, L recall (Z-1433-2010)Encore Medical, Lp2010-04-26
Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551 recall (Z-1255-2010)Encore Medical, Lp2010-04-07
Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left recall (Z-0826-2010)Encore Medical, Lp2010-02-24
Foundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design, su recall (Z-0622-2010)Encore Medical, Lp2010-01-13
Turon Revision Glenoid Poly Liner. The Metal Backed Revision Glenoid is a two piece metal recall (Z-1992-2009)Encore Medical, Lp2009-09-04
FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distr recall (Z-2466-2008)Encore Medical, Lp2008-09-29
Keramos Replacement Polyethylene Liner, 48mm; Cat. #496-28-048; Sterile, Single Use; distr recall (Z-1785-2008)Encore Medical, Lp2008-09-05
Keramos Replacement Polyethylene Liner, 52mm; Cat. #496-28-052; Sterile, Single Use; distr recall (Z-1786-2008)Encore Medical, Lp2008-09-05
Keramos Replacement Polyethylene Liner, 56mm; Cat. #496-28-056; Sterile, Single Use; distr recall (Z-1787-2008)Encore Medical, Lp2008-09-05
Keramos Replacement Polyethylene Liner, 60mm; Cat. #496-28-060; Sterile, Single Use; distr recall (Z-1788-2008)Encore Medical, Lp2008-09-05
Keramos Replacement Polyethylene Liner, 64mm; Cat. #496-28-064; Sterile, Single Use; distr recall (Z-1789-2008)Encore Medical, Lp2008-09-05
Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore Medic recall (Z-1868-2008)Encore Medical, Lp2008-08-26
3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore M recall (Z-1539-2008)Encore Medical, Lp2008-08-20
VariLift Bone Plug w/ End Cap; 14mm Dia, 24mm long; Ref #: CEA1-14-24-BP; Sterile; Encore recall (Z-0306-2008)Encore Medical, Lp2008-01-09
VariLift Bone Plug w/ End Cap; 16mm Dia, 24mm long; Ref #: CEA1-16-24-BP; Sterile; Encore recall (Z-0307-2008)Encore Medical, Lp2008-01-09
VariLift Bone Plug w/ End Cap; 18mm Dia, 24mm long; Ref #: CEA1-18-24-BP; Sterile; Encore recall (Z-0308-2008)Encore Medical, Lp2008-01-09
VariLift Bone Plug w/ End Cap; 11mm Dia, 24mm long; Ref #: CIE1-11-24-BP; Sterile; Encore recall (Z-0309-2008)Encore Medical, Lp2008-01-09
VariLift Bone Plug w/ End Cap; 13mm Dia, 24mm long; Ref #: CIE1-13-24-BP; Sterile; Encore recall (Z-0310-2008)Encore Medical, Lp2008-01-09
VariLift Bone Plug w/ End Cap; 15mm Dia, 24mm long; Ref #: CIE1-15-24-BP; Sterile; Encore recall (Z-0311-2008)Encore Medical, Lp2008-01-09
Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket Inser recall (Z-0184-2008)Encore Medical, Lp2007-12-19
Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 40 RSP Humeral Socket Inser recall (Z-0185-2008)Encore Medical, Lp2007-12-19
Foundation Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly r recall (Z-0082-2008)Encore Medical, Lp2007-11-07
Foundation Hip System Bipolar Modular, Size 41mm OD; Cat. #412-01-041; Sterile; assembly r recall (Z-0083-2008)Encore Medical, Lp2007-11-07
Foundation Hip System Bipolar Modular, Size 42mm OD; Cat. #412-01-042; Sterile; assembly r recall (Z-0084-2008)Encore Medical, Lp2007-11-07
Foundation Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; Sterile; assembly r recall (Z-0085-2008)Encore Medical, Lp2007-11-07
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Every clearance here is in the API, with alerts when new ones post.