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

Recall Z-1937-2012 — Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the nee

U.S. FDA — Device Enforcement · United States · 2012-05-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1937-2012
Date of alert: 2012-05-04
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: DePuy Mitek, Inc., a Johnson & Johnson Co.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 283904613

Reported risk: Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles

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

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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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