Z-0528-2022Class II

MAGEC 1 System

Name: Z-0528-2022 MAGEC 1 System
Creator: NuVasive Specialized Orthopedics, Inc.
Published: 2019-06-25
License: https://open.fda.gov/license/

NuVasive Specialized Orthopedics, Inc. / initiated 2019-06-25 / Open, Classified / root cause: design

FDA source

NuVasive Specialized Orthopedics, Inc. began a recall of MAGEC 1 System on 2019-06-25. FDA classified it as Class II and gives the reason as "Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0528-2022
Classification: Class II
Status: Open, Classified
Initiated: 2019-06-25
Posted: 2022-01-26
Recalling firm: NuVasive Specialized Orthopedics, Inc.
Product: MAGEC 1 System
Product code: PGN Growing Rod System- Magnetic Actuation
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.
Root cause tag: design
FDA root cause: Device Design
Action: Beginning on 06/25/2019, a Field Safety Notice was communicated to all surgeon informing them that post-implantation fracture of an internal metallic component (i.e., locking pin) has been observed in early versions of the MAGEC System Rods that were manufactured prior to March 26, 2015. Fracture of the locking pin may affect the ability of the device to lengthen and may be associated with Titanium wear debris generation and localized tissue discoloration. Recommended User Actions: - NuVasive, Inc. voluntarily issues this Safety Alert to reinforce the Instructions for Use (IFU) of the MAGEC System to clinical users - The IFU should be consulted on an ongoing basis throughout patient treatment with the MAGEC System. - Users should follow the appropriate postoperative procedure to assess the MAGEC System by X-ray imaging whenever the device is adjusted or at a minimum of once every six months. Typically, the device can be adequately visualized, and a fractured locking pin can be detected, on standard anteroposterior X-ray imaging. Figure 1 shows representative X-ray images for comparison of a device with an intact locking pin (A) to a device manufactured prior to March 26, 2015 with a fractured locking pin (B). A fractured locking pin can typically be identified by examining the noted areas to detect the separation of the internal components and/or the extension of an internal component beyond the device housing. - If a fractured locking pin is detected, removal of the device may be indicated. The decision to remove the device should be made by the physician in consultation with the patient and/or family. - If removal is deemed appropriate by the physician, the device and all associated accessories should be removed and the explanted device should be returned to NuVasive. - Clinical users should review the IFU and be aware of the warnings and precautions on an ongoing basis throughout patient treatment with the device. - Patients and/or families should be reminde
Quantity in commerce: 3,056 devices
Distribution: Worldwide
Product codes and lots: All MAGEC Systems (Serial/Lot Numbers) manufactured prior to March 26, 2015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0528-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0528-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-02	2022-01-26

Product code PGN

K140178Class IIEllipse Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc. / cleared 2014-02-27

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)