The Recall Desk

FDA (Devices) recall action 64937

DePuy Spine, Inc. recalled 3 products on 2013-09-11

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2013-09-11
Critical
0
Units
11,688

Why these products were recalled

During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2013-09-11

    DePuy Spine Recalls Confidence Spinal Cement System Kits

    DePuy Spine is recalling Confidence Spinal Cement System Kits because hydraulic pump leaks can cause loss of pressure during cement injection.

    Product
    CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyph
    Category
    Distribution
    33 states
  • HighFDA (Devices)··2013-09-11

    DePuy Spine Recalls Confidence Spinal Cement System 5cc Kits

    DePuy Spine is recalling Confidence Spinal Cement System 5cc kits because hydraulic pump leaks can cause loss of pressure during injection.

    Product
    CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or ky
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2013-09-11

    DePuy Spine Recalls Confidence Spinal Cement System Due to Pump Leak

    DePuy Spine is recalling the Confidence Spinal Cement System 11CC Plus Kit because water leaks in the hydraulic pump cause pressure loss, preventing cement injection.

    Product
    CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplast
    Category
    Distribution
    33 states