The Recall Desk

Manufacturer

DePuy Orthopaedics, Inc.

155 recalls in our database name DePuy Orthopaedics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
155
Critical
1
Severe
23
Most recent
2024-04-10

Of the 155 recalls from DePuy Orthopaedics, Inc. we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 23 (15%) are Severe.

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.

1–25 of 155

  • HighFDA (Devices)·Z-1456-2024·2024-04-10

    ATTUNE AFFIXIUM Knee Implant Component Recalled for Incorrect Labeling

    DePuy Orthopaedics is recalling ATTUNE AFFIXIUM Cementless Fixed Bearing Knee implants (Size 6) due to incorrect labeling. The affected product includes Model No. 150621006 with Lot JA06A0252.

    Product
    ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1266-2023·2023-03-29

    Attune Revision Tibial Insert Recalled for Excessive Gamma Radiation Exposure

    DePuy Orthopaedics is recalling 7 units of the Attune Revision Tibial Insert that received excess gamma radiation during manufacturing, which may degrade implant material properties.

    Product
    Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1265-2023·2023-03-29

    Attune Revision Limb Preservation System Tibial Insert Recalled for Over-Irradiation

    DePuy Orthopaedics is recalling 7 units of the Attune Revision Limb Preservation System Tibial Insert (Lot JP9022) that received higher than specified gamma radiation doses. The over-irradiation may cause changes to implant material properties.

    Product
    Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1264-2023·2023-03-29

    Orthopedic Tibial Insert Recalled Due to Excessive Radiation Exposure

    DePuy Orthopaedics is recalling Attune Revision LPS Tibial Insert devices (Lot JP9016) because they received excessive gamma radiation during manufacturing, which may compromise material properties.

    Product
    Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1267-2023·2023-03-29

    DePuy Attune Tibial Insert Recalled for Excessive Radiation Exposure

    DePuy Orthopaedics is recalling Attune Posterior tibial insert implants that received excessive gamma radiation during manufacturing, which may degrade the material properties of the knee replacement component.

    Product
    Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1263-2023·2023-03-29

    Orthopedic Implant Recall: Excessive Radiation Exposure in Revision Tibial Insert

    DePuy Orthopaedics recalls 7 units of Attune Revision LPS Tibial Inserts (Part 151760118, Lot JP6452) distributed worldwide due to excessive gamma radiation during manufacturing. This overage may result in material property changes.

    Product
    Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1419-2022·2022-07-27

    Orthopedic Surgical Guide with Defective Spring Subject to Corrosion

    DePuy Orthopaedics is recalling 872 units of the ATTUNE Measured Sizing and Rotation Guide due to a manufacturing defect. A galvanized steel spring was used instead of stainless steel, which may cause corrosion and surgical complications.

    Product
    ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1375-2022·2022-07-20

    Cathcart Hip Ball prosthesis recalled for missing surgical technique specification

    DePuy Orthopaedics is recalling Modular Cathcart Hip Ball prostheses (sizes 41-60mm) because the Instructions for Use and Surgical Technique Guide did not document a +5mm offset specification. Updated guides now clarify this for hemi-hip arthroplasty procedures.

    Product
    MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 136350000, 136351000, 136352000, 136353000, 136354000, 136356000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1029-2022·2022-05-11

    Robotic-Assisted Medical Device Recalled Due to Software Defect

    The FDA is recalling the VELYS Robotic-Assisted Solution Base due to a software defect in version 1.5.1 related to Daylight Saving Time changes. The defect can cause system errors requiring restart, potentially delaying patient treatment.

    Product
    VELYS Robotic-Assisted Solution Base Product No.: 451570100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0631-2022·2022-02-16

    Knee Replacement Component Recalled for Adhesive Residue Risk

    DePuy Orthopaedics is recalling ATTUNE Revision knee implant components due to possible adhesive residue on the surface. If undetected before surgery, the residue may cause soft tissue irritation or infection.

    Product
    ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2022·2022-02-16

    Orthopedic knee replacement component recalled for adhesive residue contamination

    DePuy Orthopaedics is recalling 3 units of ATTUNE REVISION DISTAL FEMORAL AUGMENT due to adhesive residue that could cause tissue irritation or infection if not detected before surgery.

    Product
    ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0487-2022·2022-01-19

    Orthopaedic Implant Stems Recalled for Undersized Spigot Bore Defect

    DePuy Orthopaedics is recalling GLOBAL UNITE REV STEM SZ 10 implants because the spigot bore may be undersized, preventing proper separation of components during revision surgery and potentially causing bone damage.

    Product
    GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2022·2022-01-19

    Hip Stem Device Recalled Due to Undersized Bore Diameter Risk

    DePuy Orthopaedics recalls the GLOBAL UNITE STD STEM SZ 14 hip stem in 451 units worldwide due to undersized spigot bore diameter. The defect may prevent proper separation of the stem during surgery without surgical delay or bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0486-2022·2022-01-19

    Hip stem implants recalled due to undersized bore defect

    DePuy Orthopaedics is recalling 781 hip stem implants that may have an undersized spigot bore diameter, potentially preventing surgical removal without additional surgical delay or bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2022·2022-01-19

    Hip Stem Component Recalled Due to Undersized Bore Diameter

    DePuy is recalling GLOBAL UNITE STD STEM SZ 6 orthopedic stems due to undersized spigot bore that may prevent safe removal during revision surgery, risking surgical delays and bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0490-2022·2022-01-19

    Hip prosthetic stem undersized bore complicates removal surgery

    DePuy Orthopaedics' GLOBAL UNITE STD STEM prosthetics may have undersized spigot bores, complicating removal during revision surgery. Affected patients may experience surgical delays or bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2022·2022-01-19

    DePuy Joint Stem May Have Undersized Bore, Complicating Surgical Removal

    DePuy Orthopaedics has recalled 3 units of GLOBAL UNITE REV STEM SZ 8 due to an undersized spigot bore. Separation of the implant components may not be possible without surgical delay and/or bone damage.

    Product
    GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0488-2022·2022-01-19

    Orthopaedic Stem Implants Recalled for Undersized Bore Manufacturing Defect

    DePuy Orthopaedics is recalling approximately 870 GLOBAL UNITE STD STEM implants worldwide because an undersized spigot bore may prevent proper separation, causing potential surgical delay or bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0484-2022·2022-01-19

    GLOBAL UNITE STD STEM orthopedic implant manufacturing defect recall

    DePuy Orthopaedics is recalling GLOBAL UNITE STD STEM orthopedic implants due to undersized spigot bore diameter that may prevent proper removal during revision surgery, risking surgical delay and bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0074-2022·2021-10-13

    ATTUNE Revision Tibial Augment recalled for packaging with incompatible screws

    ATTUNE Revision Tibial Augment (5mm) packaging may include incompatible screws, potentially delaying surgery. Distributed to 10 US states.

    Product
    ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2397-2021·2021-09-08

    TruMatch Surgical Instruments Recalled for Software Alignment Error

    DePuy Orthopaedics recalls TruMatch patient-specific surgical instruments due to a Fast3D software error that may misalign scanning images, potentially causing limb malalignment during surgery.

    Product
    TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2398-2021·2021-09-08

    Medical Device Recall: TruMatch CT Cut Guide Kit Software Misalignment Error

    DePuy Orthopaedics is recalling TruMatch CT Cut Guide Kits due to a software coding error in the Fast3D Segmentation software that may cause improper alignment of anatomic images, potentially resulting in limb malalignment during surgery.

    Product
    TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2399-2021·2021-09-08

    DePuy TruMatch CT Cut Guide Kit Recalled for Software Alignment Error

    DePuy's TruMatch CT Cut Guide Kit is being recalled due to a software coding error that may cause misalignment of preoperative surgical positioning scans, potentially resulting in improper limb alignment during joint replacement surgery.

    Product
    TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2396-2021·2021-09-08

    Surgical alignment software error recalled in patient-specific orthopedic instruments

    DePuy Orthopaedics recalls TruMatch surgical instruments due to a software error in the scanning alignment tool that may cause incorrect limb positioning during surgery.

    Product
    TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2400-2021·2021-09-08

    TruMatch CT Surgical Guidance Software Misalignment in Joint Replacement Instruments

    DePuy Orthopaedics' TruMatch CT surgical instrument system has a software coding error that may prevent proper alignment of scanning images, potentially causing limb malalignment during joint replacement surgery.

    Product
    TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states