Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2133-2013·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the defect results in a loss of function (inability to inject cement) rather than a direct physical injury or contamination hazard, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

DePuy Spine, Inc. is recalling the Confidence Spinal Cement System 11CC Plus Kit (Product Code: 2839-10-000). The device is intended for the percutaneous delivery of spinal cement 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 where water leaks past the piston within the pump body. This leakage results in a loss of pressure, which makes it impossible to continue injecting the cement during the procedure.

The recall covers 3,896 units distributed worldwide, including the United States and numerous international locations. Specific lot codes are listed in the agency's official record. Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for instructions on return or replacement.

The recalled product

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…
Manufacturer: DePuy Spine, Inc.
Category: Medical Device — Spinal Cement Delivery System
Hazard: device-malfunction
loss-of-pressure
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)

HPBB0K
HPBB3C
HPCB7J
HPDBD6
HPBB0L
HPBB3D
HPCB7W
HPDBF0
HPBB0M
HPBB3F
HPDBBC
HPDBG4
HPBB0N
HPBBWH
HPDBBD
HPDBGB
HPBB0P
HPBBWJ
HPDBBK
HPDBGC

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 →

Same manufacturer · DePuy Spine, Inc.

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Same hazard · device malfunction