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.

51–75 of 155

  • HighFDA (Devices)·Z-2317-2017·2017-06-14

    DePuy Synthes Orthopedic Instruments Recalled for Quality System Violations

    DePuy Orthopaedics is recalling 345 orthopedic instruments modified by U.S. distributors because they were made outside quality system regulations, potentially compromising safety and effectiveness.

    Product
    DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0703-2017·2016-12-14

    DePuy Recalls LCS Knee Revision Insert Due to Manufacturing Defect

    DePuy Orthopaedics is recalling one lot of LCS Complete Knee Revision System VVC Inserts because they were manufactured outside of specifications, preventing proper seating in the tibial tray.

    Product
    LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0650-2017·2016-11-30

    DePuy ACTIS Flex Reamers Recalled Due to Breakage Risk

    DePuy Orthopaedics is voluntarily recalling ACTIS Flex Reamers because the instruments may break and leave pieces in patients.

    Product
    ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0787-2016·2016-02-17

    DePuy SIGMA HP MBT Non-Keel Punch Knee Instrument Recalled

    DePuy Orthopaedics is recalling 351 SIGMA HP MBT Non-Keel Punch Knee Instruments due to a design defect that may cause surgical complications.

    Product
    SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0111-2016·2015-10-14

    DePuy Orthopaedics Recalls Specialist 2 Intramedullary Rod Instruments Due to Fracture Complaints

    DePuy Orthopaedics is voluntarily recalling select lots of the Specialist 2 Intramedullary Rod 400mm Instrument because the rod has fractured, leaving portions inside patients.

    Product
    Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C.¿ SIGMA¿ knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the
    Category
    Medical Device
    Distribution
    40 states
  • SevereFDA (Devices)·Z-2137-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Detachment Risk

    DePuy Orthopaedics is recalling ATTUNE FB PS Articulation Surface instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation S
    Category
    Medical Device
    Distribution
    51 states
  • SevereFDA (Devices)·Z-2138-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instrument Recall for Balseal Disassociation Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil may detach and be left in patients during surgery.

    Product
    ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Su
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2139-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Detachment Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Su
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2144-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instrument Recall for Balseal Detachment Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to pro
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2141-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instrument Recall Due to Balseal Disassociation Risk

    DePuy Orthopaedics is recalling ATTUNE RP CR Articulation Surface trial instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surf
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2140-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Detachment Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient.

    Product
    ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2142-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instrument Recall Due to Balseal Detachment Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2145-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instrument Recall Due to Balseal Detachment Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation S
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2146-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Separation Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2143-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Separation Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation S
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1672-2015·2015-06-03

    DePuy LCS COMPLETE RPS Femoral Implants Recalled for Patello-femoral Pain Risk

    DePuy Orthopaedics is recalling 19,059 LCS COMPLETE RPS Femoral Implants because they are associated with higher revision rates and potential patello-femoral pain when the native patella is not resurfaced.

    Product
    LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2015·2015-06-03

    DePuy LCS Knee Prosthesis Recalled for Higher Revision Rates

    DePuy Orthopaedics is recalling LCS COMPLETE RPS knee inserts because they show higher revision rates in Australia when the patella is not resurfaced.

    Product
    LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1357-2015·2015-04-08

    DePuy RECLAIM Hip Implant Inserter Adaptor Recalled for Fracture Risk

    DePuy Orthopaedics is recalling 54 units of the RECLAIM Assembled Implant Inserter Adaptor because the instrument may fracture during surgery, potentially leaving plastic pieces in the patient.

    Product
    RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1246-2015·2015-03-11

    DePuy Orthopaedics Recalls Partially Agglomerated SMARTSET GHV Bone Cement

    DePuy Orthopaedics is recalling one lot of SMARTSET GHV Gentamicin Bone Cement because it is partially agglomerated, which may cause surgical delays.

    Product
    SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0953-2015·2015-01-21

    DePuy ATTUNE INTUITION Impaction Handle Recalled for Fracture Risk

    DePuy Orthopaedics is recalling ATTUNE INTUITION Impaction Handles because the lever can fracture during knee surgery, potentially leaving device pieces in the patient.

    Product
    The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial impact
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0904-2015·2015-01-14

    DePuy ATTUNE INTUITION Impactors Recalled Due to Fracture Risk

    DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they may break during knee surgery, potentially leaving small fragments in the patient.

    Product
    Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0905-2015·2015-01-14

    DePuy ATTUNE INTUITION Impactors Recalled Due to Fracture Risk

    DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they have broken and produced small pieces that could be left in patients during knee replacement surgery.

    Product
    Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its rele
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0903-2015·2015-01-14

    DePuy ATTUNE INTUITION Impactors Recalled for Fracture Risk During Surgery

    DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they have broken and produced small pieces that could be left in patients during knee replacement surgery.

    Product
    Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0908-2015·2015-01-14

    DePuy I.M. Hole Locator Instrument Recalled for Fracture Risk

    DePuy Orthopaedics is recalling 1,130 I.M. Hole Locator Instruments because excessive force during use may lead to intra-operative femoral fracture.

    Product
    I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0825-2015·2014-12-24

    DePuy Ceramic Femoral Head Recalled for Fit Issues in Hip Surgery

    DePuy Orthopaedics is recalling 19 units of BIOLOX delta TS Ceramic Femoral Heads due to reports that the device did not fit as expected during hip surgery.

    Product
    Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
    Category
    Medical Device
    Distribution
    3 states