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.
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 3/5 (High).
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 involves a high-risk medical device where a mechanical failure could prevent the completion of a surgical procedure, representing a risk of harm where injury has not yet been reported.
Plain-English summary
DePuy Spine, Inc. is recalling the CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT (Product Code: 2839-05-000). 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 where water in the hydraulic pump leaks past the piston within the pump body. This leakage results in the loss of pressure and the inability to continue injecting cement during the procedure.
Approximately 3,896 units were distributed worldwide, including in the United States and numerous international markets. The source text does not specify the number of patients affected or report any specific injuries or illnesses associated with this defect.
The recalled product
- 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…
- 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 (2)
- HPBBZP
- HPDBFZ
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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