Home / Recalls / NuVasive Specialized Orthopedics, Inc. / Z-0528-2022

Z-0528-2022 Class II Ongoing

Recalled by NuVasive Specialized Orthopedics, Inc. — Aliso Viejo, CA

Recall Details

Product Type
Devices
Report Date
February 2, 2022
Initiation Date
June 25, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,056 devices

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.

Distribution Pattern

Worldwide

Code Information

All MAGEC Systems (Serial/Lot Numbers) manufactured prior to March 26, 2015.

Other recalls by NuVasive Specialized Orthopedics, Inc.

  • Z-0500-2025 Class II — Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight (September 30, 2024)
  • Z-0559-2023 Class II — NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during (November 1, 2022)
  • Z-0319-2022 Class II — NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Mod (October 29, 2021)
  • Z-1325-2021 Class II — PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed (February 12, 2021)
  • Z-1323-2021 Class II — PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed (February 12, 2021)
  • Z-1324-2021 Class II — Precice Bone Transport - Product Usage: intended for limb lengthening, open an (February 12, 2021)
  • Z-1350-2021 Class II — NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System (February 12, 2021)
  • Z-1349-2021 Class II — NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System En (February 12, 2021)
  • Z-1351-2021 Class II — NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System (February 12, 2021)
  • Z-0069-2021 Class II — NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Tr (July 24, 2020)