Magec 1
Summary
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
Nuvasive Specialized Orthopedics, Inc.
101 Enterprise, Aliso Viejo, California
United States, 92656
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