Recall Z-0358-2013— NuVasive Inc

Name: FDA recall Z-0358-2013
Creator: U.S. Food and Drug Administration
Published: 2009-01-05

Class II · Terminated

Class II FDA medical device recall by NuVasive Inc, initiated 2009-01-05, terminated 2012-11-19. It names one FDA 510(k) clearance: K082332. Product: 6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI. Reason: The tulip portion of the screw assembly can disengage from the shank after implantation..

Recalling firm: NuVasive Inc
Classification: Class II
Status: Terminated
Initiated: 2009-01-05
Terminated: 2012-11-19
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K082332 — NUVASIVE SPHERX SYSTEMNuvasive, Inc.·cleared 2008-10-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.