Recall Z-0528-2022 ยท PGN Growing Rod System- Magnetic Actuation
NuVasive Specialized Orthopedics, Inc.
MAGEC 1 System
| Date | Jun 25, 2019 |
| Status | Open, Classified |
| 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. |
| 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 |
| Quantity | 3,056 devices |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140178 | ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM Ellipse Technologies, Inc., Feb 27, 2014 |