Z-0373-2013Class II

6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

Name: Z-0373-2013 6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Creator: NuVasive Inc
Published: 2009-01-05
License: https://open.fda.gov/license/

NuVasive Inc / initiated 2009-01-05 / Terminated / root cause: design

FDA source

NuVasive Inc began a recall of 6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI on 2009-01-05. FDA classified it as Class II and gives the reason as "The tulip portion of the screw assembly can disengage from the shank after implantation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0373-2013
Classification: Class II
Status: Terminated
Initiated: 2009-01-05
Posted: 2012-11-19
Terminated: 2012-11-19
Recalling firm: NuVasive Inc
Product: 6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: The tulip portion of the screw assembly can disengage from the shank after implantation.
Root cause tag: design
FDA root cause: Device Design
Action: Telephone communications to the sales representatives of surgeons actively using the Posted Pedicle Screw System were made on 01/05/2009. The calls were unscripted and requested that all inventory be forwarded to NuVasive's San Diego office for quarantine. Surgeons who were actively using the system were also contacted and notified of the situation. Follow-up communications were sent via mail on 01/19/2009 to all surgeons who participated in the Alpha release. The letter informed the customers of the problems identified. Customers were instructed that the recalling firm does not believe any further action is required and they were instructed to monitor the progress of their patients and notify NuVasive if any issues are detected. Customers with questions or concerns are instructed to contact the firm at (858) 909-1964.
Quantity in commerce: 240 units total
Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
Product codes and lots: Batch: JK2055, JK2142, JK2172, JK2174, JK2192, JK2212, JK2173.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0373-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0348-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0349-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0350-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0351-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0352-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0353-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0354-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0355-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0356-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0357-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0358-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0359-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0360-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0361-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0362-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0363-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0364-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0365-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0366-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0367-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0368-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0369-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0370-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0371-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0372-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0373-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0374-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0375-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0376-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0377-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0378-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19

Product code NKB

K082332Class IINuvasive Spherx SystemNuvasive, Inc. / cleared 2008-10-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)