Reported Nov 28, 2012 · Terminated

7.5mm x 50mm Noncannulated 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?

  • 7.5mm x 50mm Noncannulated
  • Screw Shank Subsequent CodesKWP, KWQ, MNH, MNI
Lot codes and dates
  • Batch
    • JK2041
    • JK2146
    • JK2396
    • JK2397
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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 19, 2012 · Data as of Sep 19, 5:30 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.