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

Recall Z-0962-2013 — DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

U.S. FDA — Device Enforcement · United States · 2013-01-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0962-2013
Date of alert
2013-01-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
DePuy Spine, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
283910000
Reported risk: Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
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.

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