Reported Jul 11, 2012 · Terminated
Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The…
DePuy Mitek, Inc., a Johnson & Johnson Co.
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 Mitek, Inc., a Johnson & Johnson Co. · 325 Paramount Dr · Raynham, MA · 02767
Is this the product you have?
- Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence
- Spinal Cement System Product Code283904411. 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 needle
- Lot codes and dates
- All lots
- Amount recalled
- 704 units
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
Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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