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.

76–100 of 155

  • HighFDA (Devices)·Z-0199-2015·2014-11-19

    DePuy ATTUNE Intuition Distal Femoral Jig Recall for Bushing Defect

    DePuy Orthopaedics is recalling ATTUNE Intuition Distal Femoral Jigs because a pin bushing defect could cause the plastic to fracture or displace during use.

    Product
    ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0061-2015·2014-10-15

    DePuy Charnley Pin Retractor and Handle Set Recalled for Component Breakage

    DePuy Orthopaedics is recalling 65 units of the Charnley Pin Retractor and Handle Set because the small extraction peg is breaking from the pin.

    Product
    Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0038-2015·2014-10-15

    DePuy Orthopaedics Recalls RECLAIM Distal Reamer Extension Devices

    DePuy Orthopaedics is recalling 875 units of RECLAIM Distal Reamer Extension devices because the tabs may break and leave fragments in the patient.

    Product
    RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-2082-2014·2014-07-30

    DePuy RECLAIM Taper Protector Sleeve Recalled for Removal Difficulty

    DePuy Orthopaedics is recalling 814 RECLAIM Taper Protector Sleeves because the product can be difficult to remove from the Distal Stem.

    Product
    RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-2084-2014·2014-07-30

    DePuy RECLAIM Taper Protector Sleeve Recalled for Removal Difficulty

    DePuy Orthopaedics is recalling RECLAIM Taper Protector Sleeves because they can be difficult to remove from the Distal Stem.

    Product
    RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-2083-2014·2014-07-30

    DePuy Orthopaedics Recalls RECLAIM Distal Tapered Surgical Instruments

    DePuy Orthopaedics is recalling RECLAIM Distal Tapered surgical instruments because they can be difficult to remove from the Distal Stem.

    Product
    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1437-2014·2014-04-16

    DePuy Shoulder Guide Pin Recall Due to Breakage Risk

    DePuy Orthopaedics is recalling 21,675 GLOBAL Anchor Peg Glenoid Plus 2.5mm Breakaway Guide Pins because they may break and be left in patients during surgery.

    Product
    GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product Usage: Usage: The GLOBAL APG+ 2.5mm Guide Pin is a single-use instrument that is used to assist the surgeon in the orientation of the cannulat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1207-2014·2014-03-19

    DePuy S-ROM Noiles Rotating Hinge Femur Recall for Sterile Barrier Defect

    DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches, potentially compromising sterility.

    Product
    REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1205-2014·2014-03-19

    DePuy S-ROM Noiles Rotating Hinge Femur Recall for Sterile Barrier Defect

    DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches, potentially compromising sterility.

    Product
    REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is nee
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1204-2014·2014-03-19

    DePuy S-ROM Noiles Rotating Hinge Femur Recalled for Sterile Barrier Defects

    DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches, potentially compromising sterility.

    Product
    REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2014·2014-03-19

    DePuy S-ROM Noiles Rotating Hinge Femur Recall for Sterile Barrier Defects

    DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices due to potential holes in the sterile barrier pouches.

    Product
    REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1206-2014·2014-03-19

    DePuy S-ROM Rotating Hinge Femoral Components Recalled for Sterile Barrier Defects

    DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femoral components due to potential holes in the sterile barrier pouches.

    Product
    REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is nee
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1203-2014·2014-03-19

    DePuy S-ROM Rotating Hinge Recall Due to Sterile Barrier Defect

    DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches.

    Product
    REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is ne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1077-2014·2014-03-05

    DePuy PFC SIGMA Knee Implant Recall Due to Microstructure Defects

    DePuy Orthopaedics is recalling PFC SIGMA knee implants with anomalous microstructure that may decrease fatigue strength and cause fracture.

    Product
    PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0415-2014·2013-12-04

    DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and be left in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0417-2014·2013-12-04

    DePuy Orthopaedics Recalls HP M.B.T. Keel Punch Knee Instruments

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0423-2014·2013-12-04

    DePuy Orthopaedics Recalls HP M.B.T. Keel Punch Knee Instruments

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0421-2014·2013-12-04

    DePuy Orthopaedics Recalls HP M.B.T. Keel Punch Knee Instruments

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0413-2014·2013-12-04

    DePuy Orthopaedics Recalls HP M.B.T. Keel Punch Knee Instruments

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0418-2014·2013-12-04

    DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2014·2013-12-04

    DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0419-2014·2013-12-04

    DePuy Recalls Knee Instruments Due to Potential Tab Fracture

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs may fracture and remain in patients.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0420-2014·2013-12-04

    DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2014·2013-12-04

    DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0414-2014·2013-12-04

    DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide