FDA Device recall Z-2132-2013
CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous deliver…
- FDA Device
- Class II
- terminated
- Published 2013-09-11
On 2013-09-11 the FDA classified a Class II recall of CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous deliver… by Depuy Spine, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2132-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-17 |
| Published | 2013-09-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Depuy Spine |
| Distribution | AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV, WY |
Product
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.
Reason
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.
Identifiers
| code_info | HPBBZP, HPDBFZ |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2132-2013%22
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