DePuy Spine Recalls Cement Mixer Kits Due to Jamming Risk
DePuy Spine is recalling CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus kits because the cement mixer may jam or fail to turn properly 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 defect in a surgical device that could lead to improper cement preparation, 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 11C Plus KIT, Catalog Number 283910000. The recall involves 7,773 units distributed worldwide, including the United States and numerous international markets. The product is indicated for the delivery of CONFIDENCE Spinal Cement, which is used for the fixation of pathological fractures.
The recall was initiated because the cement mixer used to prepare the cement for surgery may not turn properly and may jam or get stuck. This mechanical defect could interfere with the proper preparation of the spinal cement during surgical procedures.
Healthcare providers and patients who have used or may use these kits should contact DePuy Spine, Inc. for further instructions on how to manage the affected devices. The recall covers all lots of the specified catalog number.
The recalled product
- Product
- DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
- Manufacturer
- DePuy Spine, Inc.
- Affected units
- 7,773
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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