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Terminated

6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

FDA Recall Z-0359-2013 · Posted 2012-11-19

Recalling FirmNuVasive Inc
Recall StatusTerminated
Product CodeNKB
Date Initiated2009-01-05
Date Terminated2012-11-19
Product Quantity240 units total

Reason for Recall

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082332NUVASIVE SPHERX SYSTEMNuvasive, Inc. · 2008-10-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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