Magec 2 Device
Summary
Contact the manufacturer if you require additional information.
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 |
Magec 2 (Marketed As Magec X) Device (Various Rod Sizes And Lot Numbers) |
More than 10 numbers, contact manufacturer. |
MS2-6090R |
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
Nuvasive Specialized Orthopedics, Inc.
101 Enterprise, Aliso Viejo, California, United States, 92656