DePuy Confidence Spinal Cement Mixer Recall for Jamming Defect
DePuy Spine is recalling the Confidence Spinal Cement System 5cc Kit because the cement mixer may not turn properly and may jam or get stuck during surgery.
What this means for you
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 compromise the procedure, 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 the DePuy Confidence Spinal Cement System 5cc Kit, Catalog Number 283905000. The product is indicated for the delivery of Confidence Spinal Cement, which is used for the fixation of pathological fractures. The recall affects 1,023 units distributed worldwide, including the United States and numerous international markets.
The recall was initiated because the cement mixer used to prepare the cement for surgery may not turn properly. The device may jam or get stuck during use. This defect could interfere with the proper preparation of the spinal cement during surgical procedures.
Healthcare providers and facilities that have received this product should stop using it and contact DePuy Spine, Inc. for further instructions on how to return or dispose of the affected units. Patients who have already had surgery using this product should contact their healthcare provider if they have concerns about the procedure.
The recalled product
- Product
- DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
- Manufacturer
- DePuy Spine, Inc.
- Affected units
- 1,023
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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