The Recall Desk

FDA (Devices) recall action 63783

DePuy Orthopaedics, Inc. recalled 4 products on 2013-02-27

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2013-02-27
Critical
0
Units
—

Why these products were recalled

DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.

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

States named across these recalls

1–4 of 4

  • SevereFDA (Devices)··2013-02-27

    DePuy LPS Diaphyseal Sleeves Recalled for Potential Fracture Risk

    DePuy Orthopaedics is voluntarily recalling LPS Diaphyseal Sleeves due to a potential fracture risk at the taper junction during normal gait activities.

    Product
    LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
    Category
    Distribution
    26 states
  • SevereFDA (Devices)··2013-02-27

    DePuy LPS Diaphyseal Sleeves Recalled for Potential Taper Fracture

    DePuy Orthopaedics is voluntarily recalling LPS Diaphyseal Sleeves because the taper connection may fracture under normal gait loads.

    Product
    LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
    Category
    Distribution
    26 states
  • SevereFDA (Devices)··2013-02-27

    DePuy LPS Diaphyseal Sleeves Recalled for Potential Taper Fracture

    DePuy Orthopaedics is voluntarily recalling LPS Diaphyseal Sleeves because the taper connection may fracture under normal gait loads.

    Product
    LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
    Category
    Distribution
    26 states
  • SevereFDA (Devices)··2013-02-27

    DePuy LPS Diaphyseal Sleeves Recalled for Potential Taper Fracture

    DePuy Orthopaedics is voluntarily recalling LPS Diaphyseal Sleeves because the taper connection may fracture under normal physiologic loads.

    Product
    LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
    Category
    Distribution
    26 states