The Recall Desk

FDA (Devices) recall action 66864

DePuy Orthopaedics, Inc. recalled 12 products on 2013-12-04

The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products
12
Announced
2013-12-04
Critical
0
Units
—

Why these products were recalled

DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–12 of 12

  • HighFDA (Devices)··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
    Distribution
    28 states
  • SevereFDA (Devices)··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
    Distribution
    28 states
  • SevereFDA (Devices)··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
    Distribution
    28 states
  • HighFDA (Devices)··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
    Distribution
    28 states
  • HighFDA (Devices)··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
    Distribution
    28 states
  • SevereFDA (Devices)··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
    Distribution
    28 states
  • HighFDA (Devices)··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
    Distribution
    28 states
  • SevereFDA (Devices)··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
    Distribution
    28 states
  • SevereFDA (Devices)··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
    Distribution
    28 states
  • HighFDA (Devices)··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
    Distribution
    28 states
  • HighFDA (Devices)··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
    Distribution
    28 states
  • HighFDA (Devices)··2013-12-04

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

    DePuy Orthopaedics is 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 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
    Distribution
    28 states