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

Recall Z-1300-2018 — Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathologi

U.S. FDA — Device Enforcement · United States · 2017-12-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1300-2018
Date of alert: 2017-12-15
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: Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.

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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