FDA-Device2012-11-28Class II

7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc
Hazard

The tulip portion of the screw assembly can disengage from the shank after implantation.

Sold states
Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
Affected count
240 units total
Manufactured in
7475 Lusk Blvd, N/A, San Diego, CA, United States
Products
7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0366-2013

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