Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Recalled by DePuy Spine, Inc. Due to During injection of cement, the water in the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DePuy Spine, Inc. directly.
Affected Products
CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 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.
Quantity: 3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways)
Why Was This 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.
Where Was This Sold?
This product was distributed to 33 states: AZ, AR, CA, CO, CT, FL, GA, HI, ID, IN, IA, KY, LA, MD, MA, MI, MN, MO, NE, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV, WY
About DePuy Spine, Inc.
DePuy Spine, Inc. has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report