Reported Sep 11, 2013 · Terminated
CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for…
DePuy Spine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Spine, Inc. · 325 Paramount Dr · Raynham, MA · 02767-5199
Is this the product you have?
- CONFIDENCE SPINAL CEMENT SYSTEM KIT
- Product Code2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures
- Lot codes and dates
HPBB0BHPBBWMHPCB75HPCCBNHPBB0RHPBBWPHPCB7DHPDBBVHPBB28HPBBZ7HPCB7FHPDBCGHPBB2DHPBBZFHPCB7THPDBD1HPBB2FHPBCKHHPCB7VHPDBD5HPBB4RHPBDL9HPCB8GHPDBF9HPBBV1HPCB67HPCBLCHPDBGHHPBBWGHPCB68HPCBM1HPDBGKHPBBWKHPCB74HPCCBMHPDBGL
- Amount recalled
- 3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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