Reported Mar 27, 2013 · Terminated

DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is…

DePuy Spine, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DePuy Spine, Inc. · 325 Paramount Dr · Raynham, MA · 02767-5199

Is this the product you have?

  • DePuy CONFIDENCE
  • SPINAL CEMENT SYSTEM KIT Catalog Number283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures
Lot codes and dates
  • All lots
Amount recalled
6668

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 30, 2014 · Data as of Sep 19, 6:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.