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:
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-63804
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