DePuy Spine Recalls CONFIDENCE Spinal Cement System Kits
DePuy Spine is recalling CONFIDENCE Spinal Cement System Kits because the cement mixer may not turn properly and could jam or get stuck during surgery.
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 is classified as FDA Class II, and the hazard involves a mechanical failure (jamming) of a surgical device that poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
DePuy Spine, Inc. is recalling the CONFIDENCE SPINAL CEMENT SYSTEM KIT (Catalog Number: 283913000). This product is indicated for the delivery of CONFIDENCE Spinal Cement, which is used for the fixation of pathological fractures.
The recall is being issued because the cement mixer used to prepare the cement for surgery may not turn properly. The mixer may jam or get stuck during use. The recall covers 6,668 units distributed worldwide, including the United States and numerous international markets.
Healthcare providers and patients should contact DePuy Spine, Inc. for further information regarding this recall and potential corrective actions.
The recalled product
- Product
- DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
- Manufacturer
- DePuy Spine, Inc.
- Affected units
- 6,668
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 (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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