The Recall Desk

Manufacturer

Encore Medical, LP

46 recalls in our database name Encore Medical, LP as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–46 of 46

  • HighFDA (Devices)·Z-0532-2024·2023-12-20

    Shoulder Implant Recall: RSP Glenoid Baseplate Assembly Defect

    Encore Medical recalls RSP Glenoid Baseplate shoulder implants due to a manufacturing defect in the hex engagement mechanism. The defect could prevent proper installation of the device.

    Product
    RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0508-2024·2023-12-13

    DJO EMPOWR Knee System Recall: Incorrect Device in Packaging

    Encore Medical is recalling 37 DJO surgical EMPOWR Porous Knee System SIZE 8 devices distributed nationwide because incorrect product components were packaged with certain units.

    Product
    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", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0281-2024·2023-11-15

    RSP Humeral Socket Inserts Swapped During Packaging by Encore Medical

    Two different RSP humeral socket insert devices were swapped during packaging at Encore Medical. This could result in surgeons receiving an incorrect device for shoulder surgery, potentially delaying the procedure.

    Product
    RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0258-2024·2023-11-15

    DJO EMPOWR Knee Punch Handle Tip May Break During Surgery

    Encore Medical is recalling DJO EMPOWR Knee Punch Handles due to a manufacturing defect that may cause the handle tip to break during surgery, potentially disrupting the procedure.

    Product
    DJO EMPOWR Knee Punch Handle, REF: 801-05-040
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-0282-2024·2023-11-15

    Orthopedic Shoulder Implant Devices Recalled Due to Packaging Mix-Up

    Encore Medical recalls RSP Humeral Socket Insert implant components due to a packaging error where two different devices were swapped. This could prevent surgeons from having the correct implant available during shoulder surgery.

    Product
    RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0098-2024·2023-10-18

    Reverse Shoulder Prosthesis Screws May Have Incorrect Size

    Reverse shoulder prosthesis packages labeled as containing 5mm x 30mm screws may instead contain incorrect 3.5mm x 30mm screws. Using the wrong size screws could cause surgical delay and inadequate fixation.

    Product
    REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0102-2024·2023-10-18

    Knee Tibial Insert Recalled Due to Component Mix-Up in Packaging

    Encore Medical is recalling the EMPOWR 3D Knee Tibial Insert due to a packaging error where hip and knee components were swapped, potentially causing surgeons to use the wrong implant during surgery.

    Product
    EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0103-2024·2023-10-18

    EMPOWR hip acetabular implant packaging incorrectly contains knee implant component

    Encore Medical recalled 20 units of EMPOWR Acetabular System hip implant liners after knee implant components were mistakenly placed in hip surgery packages. Surgeons using the wrong implant could receive an anatomically incompatible component.

    Product
    EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2603-2023·2023-09-27

    Orthopedic knee implant component lacks final sterilization before shipment

    Encore Medical recalls 20 DJO Surgical Empowr Knee tibia baseplate components that were not sterilized before shipment. If implanted, these components may cause infection requiring treatment or revision surgery.

    Product
    DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2606-2023·2023-09-27

    DJO Surgical Reverse Shoulder System Components Recalled Due to Missing Sterilization

    Reverse shoulder implant components were shipped without final sterilization, potentially leading to infection and possible revision surgery if implanted. Encore Medical is recalling 64 units distributed across the US and internationally.

    Product
    DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm, REF: 508-36-101
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2604-2023·2023-09-27

    DJO Surgical Orthopedic Implants Recalled for Sterilization Failure

    DJO Surgical orthopedic implants (lot 878B1171) were shipped without sterilization and may cause infection if implanted, potentially requiring treatment, monitoring, or revision surgery. Contact your healthcare provider to verify your lot number.

    Product
    DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2605-2023·2023-09-27

    Orthopedic hip stem implant recalled due to sterilization failure

    Encore Medical has recalled a hip stem orthopedic implant that was not sterilized before shipment. Non-sterile implants may cause infection if implanted, requiring treatment and potentially revision surgery.

    Product
    DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2607-2023·2023-09-27

    Orthopedic implant components recalled due to sterilization failure

    Encore Medical is recalling 15 orthopedic implants (DJO Surgical Altivate Reverse) due to sterilization failure. If implanted, unsterilized components may cause infection requiring treatment, monitoring, or revision surgery.

    Product
    DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1384-2023·2023-04-19

    Knee Patella Drills Recalled for Incorrect Diameter Markings

    Encore Medical is recalling EMPOWR Knee Patella drills due to reversed diameter markings that could cause incorrect drill selection during surgery, leading to implant loosening or bone fracture.

    Product
    EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1187-2023·2023-03-08

    EMPOWR VVC Knee Tibial Insert Recalled for Reversed Box Labeling

    Encore Medical recalls EMPOWR VVC Knee Tibial Inserts due to reversed box labeling—large inserts marked as small and vice versa. Surgeons may implant the wrong size if the labeling discrepancy is not identified before surgery.

    Product
    EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22-708; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 9, 22MM, REF: 346-22-709; EMPOWR VVC KNEE TIBIAL INSERT, S
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0125-2023·2022-11-02

    Hip Liner Implants Mixed with Knee Inserts in Packaging

    Encore Medical is recalling EMPOWR hip liner implants because boxes may contain knee inserts instead. This packaging error could delay surgeries. Four units affected in six US states.

    Product
    EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0126-2023·2022-11-02

    EMPOWER 3D Knee Tibial Insert Recall Due to Packaging Mix-Up

    Hip and knee implant boxes from Encore Medical may contain the wrong product, potentially causing surgery delays. The FDA is recalling affected units to prevent unavailability of correct implants.

    Product
    EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1257-2022·2022-06-15

    DJO EMPOWR 3D Knee Tibial Insert Mispackaged—Risk of Wrong Implant

    Encore Medical is recalling DJO EMPOWR 3D Knee tibial inserts because packages may contain a mismatched left-size component instead of the correct right-size implant. If implanted, the wrong component could leave debris in the joint.

    Product
    DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2331-2021·2021-09-01

    FDA Recalls AltiVate Shoulder Implant System Due to Component Mating Failure

    The FDA is recalling AltiVate Anatomic Shoulder Systems due to humeral stem components that may fail to mate properly with broach handles, potentially delaying surgery or requiring revision.

    Product
    AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-2104-2021·2021-07-28

    DJO Surgical EMPOWR 3D Knee Tibial Insert packaging may contain wrong implant size

    Packaging for DJO Surgical EMPOWR 3D Knee Tibial Insert knee prosthesis implants may be mislabeled, with 12mm packages potentially containing 16mm implants or vice versa, risking incorrect surgical implantation.

    Product
    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2021·2021-07-28

    Knee Prosthesis Recall: Packaging Mixup May Cause Wrong Size Implantation

    Encore Medical recalls DJO Surgical EMPOWR 3D knee prosthetic components because packaging labels may not match the product inside, risking implantation of incorrect prosthesis sizes.

    Product
    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
    Category
    Medical Device
    Distribution
    Distributed nationwide