The Recall Desk
HighFDA (Devices)·Z-2134-2013·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the defect presents a risk of harm (inability to complete a surgical procedure) where specific injury reports are not detailed in the source text.

Plain-English summary

DePuy Spine, Inc. is recalling the Confidence Spinal Cement System Kit (Product Code: 2839-13-000). The device is intended for the percutaneous delivery of Confidence Spinal Cement, which is indicated for the fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.

The recall is due to a defect in the hydraulic pump. During the injection of cement, water in the hydraulic pump may leak past the piston within the pump body. This leak results in the loss of pressure and the inability to continue injecting the cement.

The recall covers 3,896 units distributed worldwide, including the United States and numerous international markets. The source text does not specify the number of reported injuries or illnesses associated with this defect.

The recalled product

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
Manufacturer
DePuy Spine, Inc.
Category
Medical Device — Orthopedic / Spinal
Hazard
Affected units
3,896

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • HPBB0B
  • HPBBWM
  • HPCB75
  • HPCCBN
  • HPBB0R
  • HPBBWP
  • HPCB7D
  • HPDBBV
  • HPBB28
  • HPBBZ7
  • HPCB7F
  • HPDBCG
  • HPBB2D
  • HPBBZF
  • HPCB7T
  • HPDBD1
  • HPBB2F
  • HPBCKH
  • HPCB7V
  • HPDBD5

Distribution

Distributed in 33 states:

Part of a larger recall action

This product is one of 3 recalled by DePuy Spine, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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