Health product recall

Magec 1

Last updated

Summary

Product
Magec 1
Issue
Medical devices - Revised instructions for use
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Magec 1

More than 10 numbers, contact manufacturer.

RA002-5555SL70, RA002-5555SL, RA002-4545SL, RA002-4545SL70

Issue

Post-implantation fracture of an internal metallic component (i.e., locking pin) had been observed in early version of Magec rods that were manufactured prior to March 26, 2015. In June 2019, Nuvasive Specialized Orthopedics issued a safety alert to inform users that the safety alert incorrectly stated that the device should be removed after an implantation time of no more than six years. Per the IFU, the device should be removed after implantation time of no more than two years.

Recall start date: Jan 31, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies

Nuvasive Specialized Orthopedics, Inc.

101 Enterprise, Aliso Viejo, California

United States, 92656

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63923

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe