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.
What this means for you
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 vertebroplast
- Manufacturer
- DePuy Spine, Inc.
- 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
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.
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