Reported Nov 28, 2012 · Terminated
5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive 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: NuVasive Inc · 7475 Lusk Blvd · San Diego, CA · 92121-5707
Is this the product you have?
- 5.5mm x 30mm
- Cannulated Screw Shank Subsequent CodesKWP, KWQ, MNH, MNI
- Lot codes and dates
- BatchJK2053
- Amount recalled
- 240 units total
This recall covers 31 products
The agency filed one notice per product. You are reading one of them; the other 30 are below.
18 more are in the archive.
Where it was sold
Why it was recalled
The tulip portion of the screw assembly can disengage from the shank after implantation.
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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