Recall Z-0528-2022— NuVasive Specialized Orthopedics, Inc.

Name: FDA recall Z-0528-2022
Creator: U.S. Food and Drug Administration
Published: 2019-06-25

Class II · Ongoing

Class II FDA medical device recall by NuVasive Specialized Orthopedics, Inc., initiated 2019-06-25. It names one FDA 510(k) clearance: K140178. Product: MAGEC 1 System. Reason: Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015..

Recalling firm: NuVasive Specialized Orthopedics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2019-06-25
Firm location: Aliso Viejo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K140178 — ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEMEllipse Technologies, Inc.·cleared 2014-02-27

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

MAGEC 1 System

Reason for recall

Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.

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