Magec 2 Device
Last updated
Summary
Product
Magec 2 Device
Issue
Medical devices - Sterility Issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products | Lot or serial number | Model or catalogue number |
---|---|---|
Magec 2 (Marketed As Magec X) Device (Various Rod Sizes And Lot Numbers) | More than 10 numbers, contact manufacturer. | MC2-5590S MC2-6090S MC2-4570S MC2-5070S MC2-4590S MC2-5090S MC2-5570S MC2-6070S |
Magec 2 (Marketed As Magec X) Device (Various Rod Sizes And Lot Numbers) | More than 10 numbers, contact manufacturer. | MS2-6090R MC2-4590R MC2-5070R MC2-4570R MC2-5590R MC2-6070R MC2-5570R MC2-5090R |
Issue
Recall relates to a packaging closure integrity issue. Investigation revealed a small population (3.8%) of packaged units have an undersized o-ring gland diameter that can affect the o-ring compression when the hard cap is affixed to the packaging tube. This lack of full compression can create a situation where the integrity of the container closure system is compromised potentially impacting the sterile barrier system.
Recall start date: November 1, 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
Healthcare
Recall class
Type II
Identification number
RA-72218
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