Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2134-2013 — CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 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.

U.S. FDA — Device Enforcement · United States · 2013-04-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2134-2013
Date of alert: 2013-04-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: DePuy Spine, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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