Reported Dec 28, 2016 · Terminated
Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet…
Amendia, 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: Amendia, Inc · 1755 W Oak Pkwy · Marietta, GA · 30062-2260
Is this the product you have?
- Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
- Lot codes and dates
Part Number 812-11R-15 Lot Number 12194512323112414612541812682212786812845912846413081813149213496132594132813134514134515134517134909135290137302
- Amount recalled
- 1078 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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