FDA (Devices) recall action 64072
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
DePuy Spine is recalling CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus kits because the cement mixer may jam or fail to turn properly during surgery.
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.
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.
DePuy Spine is recalling 549 CONFIDENCE Spinal Cement System kits because the cement mixer may jam or fail to turn properly during surgery.