Health product recall

Precice System

Last updated

Summary

Product
Precice System
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

Precice System

All lots

STU1-001

Issue

NSO is notifying that the products outlined are not indicated for use in individuals under the age of 18 years old. Also, NSO intends to make users aware of the gaps in the biological assessments for these devices as outlined in ISO 10993-1:2018 biological evaluation of medical device.

Recall start date: Feb 1, 2021

Additional information

Details
Original published date: 2022-01-13
Alert / recall type
Health product recall
Category
Health product - Medical device - 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-63804