Z-0528-2022 Class II Ongoing
FDA device recall Z-0528-2022 was initiated by NuVasive Specialized Orthopedics, Inc. on June 25, 2019 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 3,056 devices.
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.