DePuy Spine Recalls Cement Mixer Kits Due to Jamming Risk
DePuy Spine is recalling 549 CONFIDENCE Spinal Cement System 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. The hazard involves a mechanical failure (jamming) of a surgical device that could impact patient safety, but the source text does not report any specific injuries, illnesses, or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DePuy Spine, Inc. is recalling 549 units of the CONFIDENCE Spinal Cement System 7CC Kit (Catalog Number: 283907000). The product is indicated for the fixation of pathological fractures. The recall covers all lots of this specific catalog number.
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 defect could interfere with the proper preparation of the spinal cement during a surgical procedure.
The affected products were distributed worldwide, including in the United States and numerous international markets such as Argentina, Australia, Brazil, Canada, China, and the United Kingdom. Healthcare providers and facilities that have received these kits should stop using them and contact DePuy Spine for further instructions on the recall process.
The recalled product
- Product
- DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
- Manufacturer
- DePuy Spine, Inc.
- Affected units
- 549
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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