NuVasive Inc: Medical Device Recall in 2012 - (Recall #: Z-0352-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.
Product Description:

5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

Product Classification:

Class II

Date Initiated: January 5, 2009
Date Posted: November 28, 2012
Recall Number: Z-0352-2013
Event ID: 52634
Reason for Recall:

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

Status: Terminated
Product Quantity: 240 units total
Code Information:

Batch: JK2058, JK2054, JK2081, JK2143

Distribution Pattern:

Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.

Voluntary or Mandated:

Voluntary: Firm initiated