Encore Medical recalls
Encore Medical appears in 99 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-15.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 99 |
|---|---|
| Published | 2012-08-15 to 2026-07-15 |
| By agency | FDA Device (99) |
| By classification | Class II (99) |
| By status | ongoing (59), terminated (33), completed (7) |
| Distribution named in notices | AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee…
FDA Device · Class II · 2026-07-15 · Encore Medical
Reason: Due to packaging discrepancy with incorrect product size mixed up. - Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee…
FDA Device · Class II · 2026-07-15 · Encore Medical
Reason: Due to packaging discrepancy with incorrect product size mixed up. - Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 5…
FDA Device · Class II · 2026-03-04 · Encore Medical
Reason: Knee and Humeral socket implants contain incorrect labeling. - Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00…
FDA Device · Class II · 2026-03-04 · Encore Medical
Reason: Knee and Humeral socket implants contain incorrect labeling. - Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
FDA Device · Class II · 2026-03-04 · Encore Medical
Reason: Knee and Humeral socket implants contain incorrect labeling. - EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
FDA Device · Class II · 2026-02-11 · Encore Medical
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 t… - EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H
FDA Device · Class II · 2026-02-11 · Encore Medical
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 t… - Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Des…
FDA Device · Class II · 2025-09-17 · Encore Medical
Reason: Their is a potential that the reamer may kick or bind up during or immediately prior to use. - Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: M…
FDA Device · Class II · 2025-09-17 · Encore Medical
Reason: Their is a potential that the reamer may kick or bind up during or immediately prior to use. - Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Mat…
FDA Device · Class II · 2025-09-17 · Encore Medical
Reason: Their is a potential that the reamer may kick or bind up during or immediately prior to use. - Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Descripti…
FDA Device · Class II · 2025-09-17 · Encore Medical
Reason: Their is a potential that the reamer may kick or bind up during or immediately prior to use. - Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product De…
FDA Device · Class II · 2025-08-20 · Encore Medical
Reason: Knee implants contain incorrect labeling (size and/or side incorrect) - Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product De…
FDA Device · Class II · 2025-08-20 · Encore Medical
Reason: Knee implants contain incorrect labeling (size and/or side incorrect) - Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E…
FDA Device · Class II · 2025-07-30 · Encore Medical
Reason: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint. - Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F…
FDA Device · Class II · 2025-07-30 · Encore Medical
Reason: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint. - Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Softwar…
FDA Device · Class II · 2025-07-23 · Encore Medical
Reason: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used. - Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Softwar…
FDA Device · Class II · 2025-07-23 · Encore Medical
Reason: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used. - Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version:…
FDA Device · Class II · 2025-07-02 · Encore Medical
Reason: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. - Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version:…
FDA Device · Class II · 2025-07-02 · Encore Medical
Reason: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. - Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version:…
FDA Device · Class II · 2025-07-02 · Encore Medical
Reason: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. - Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version:…
FDA Device · Class II · 2025-07-02 · Encore Medical
Reason: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. - EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
FDA Device · Class II · 2025-01-01 · Encore Medical
Reason: Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product. - EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705
FDA Device · Class II · 2025-01-01 · Encore Medical
Reason: 5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product. - REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
FDA Device · Class II · 2024-01-10 · Encore Medical
Reason: Mislabeling - Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
FDA Device · Class II · 2024-01-10 · Encore Medical
Reason: Mislabeling - RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204
FDA Device · Class II · 2023-12-20 · Encore Medical
Reason: Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver - DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE",…
FDA Device · Class II · 2023-12-13 · Encore Medical
Reason: Due to incorrect product/device within packaging. - RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component
FDA Device · Class II · 2023-11-15 · Encore Medical
Reason: Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery. - DJO EMPOWR Knee Punch Handle, REF: 801-05-040
FDA Device · Class II · 2023-11-15 · Encore Medical
Reason: Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery. - RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component
FDA Device · Class II · 2023-11-15 · Encore Medical
Reason: Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery. - REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
FDA Device · Class II · 2023-10-18 · Encore Medical
Reason: Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation. - EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H
FDA Device · Class II · 2023-10-18 · Encore Medical
Reason: Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different an… - EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
FDA Device · Class II · 2023-10-18 · Encore Medical
Reason: Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different an… - DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032
FDA Device · Class II · 2023-09-27 · Encore Medical
Reason: Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to rev… - DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
FDA Device · Class II · 2023-09-27 · Encore Medical
Reason: Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to rev… - DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
FDA Device · Class II · 2023-09-27 · Encore Medical
Reason: Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to rev… - DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
FDA Device · Class II · 2023-09-27 · Encore Medical
Reason: Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to rev… - DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
FDA Device · Class II · 2023-09-27 · Encore Medical
Reason: Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to rev… - EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104
FDA Device · Class II · 2023-04-19 · Encore Medical
Reason: Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill… - EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706
FDA Device · Class II · 2023-03-08 · Encore Medical
Reason: Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discr… - EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component
FDA Device · Class II · 2022-11-02 · Encore Medical
Reason: Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery. - EMPOWER 3D Knee Tibial Insert, REF: 341-14-708
FDA Device · Class II · 2022-11-02 · Encore Medical
Reason: Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery. - DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
FDA Device · Class II · 2022-06-15 · Encore Medical
Reason: A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space. - AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev
FDA Device · Class II · 2021-09-01 · Encore Medical
Reason: Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery. - DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
FDA Device · Class II · 2021-07-28 · Encore Medical
Reason: Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis. - DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
FDA Device · Class II · 2021-07-28 · Encore Medical
Reason: Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis. - DJO EMPOWR KNEE Femoral Sizer
FDA Device · Class II · 2021-05-12 · Encore Medical
Reason: Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction. - EMPOWR Partial Knee Peg Drill Guide
FDA Device · Class II · 2020-12-02 · Encore Medical
Reason: There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The ext… - EMPOWR Partial Knee Peg Drill
FDA Device · Class II · 2020-12-02 · Encore Medical
Reason: There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The ext… - AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical should…
FDA Device · Class II · 2020-10-28 · Encore Medical
Reason: Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.